This job has expired

About the Role

• Prepare and submit regulatory documentation and product registration dossiers
• Maintain regulatory approvals, licences, and certificates across the portfolio
• Coordinate renewals to ensure continuous market access

• Develop and maintain Technical Documentation in line with EU MDR (2017/745) and ISO 13485
• Support clinical evaluation activities, including plans, reports, and post-market clinical follow-up
• Ensure labelling and marketing materials comply with regulatory standards
• Contribute regulatory expertise during product design and development

• Monitor changes in global regulations, standards, and guidance
• Assess impact and support implementation across processes and documentation
• Maintain regulatory tracking systems and databases

• Support audits and inspections (Notified Bodies and Competent Authorities)
• Contribute to vigilance and post-market surveillance activities
• Assist in maintaining and improving the Quality Management System

• Work closely with Quality, Clinical, Marketing, R&D, and Operations teams
• Provide regulatory input for product launches, updates, and discontinuations
• Support business-wide understanding of regulatory requirements

• 5+ years in Regulatory Affairs within the medical device industry
• Strong knowledge of EU MDR (2017/745), ISO 13485, and global regulatory frameworks
• Proven experience with:
  • Technical documentation and regulatory submissions
  • Product registrations and regulatory approvals
  • Clinical evaluation (CERs, CEPs, literature reviews)
• Solid understanding of:
  • Labelling compliance
  • Product classification and regulatory pathways
• Experience with post-market surveillance and vigilance activities

• Strong communicator able to translate regulatory requirements into practical guidance
• Collaborative approach with cross-functional teams
• Detail-oriented with excellent organisational skills
• Proactive and able to manage multiple priorities

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.

Cure Talent are delighted to be partnered with an established medical device manufacturer with a long-standing portfolio of Class I and Class IIa medical devices supplied across the UK and European markets. Due to continued growth, they are now looking to appoint a Regulatory Affairs Specialist to join their Quality & Regulatory team based in Bromsgrove.

As the new Regulatory Affairs Specialist, you will play a key role in ensuring ongoing compliance with UK MDR and EU MDR requirements, supporting products throughout the full lifecycle from development through to post-market activities. Working closely with the QA Manager, you will be responsible for maintaining technical documentation, supporting regulatory submissions, liaising with regulatory bodies, and contributing to the continued development of the Quality Management System.

To be successful as the new Regulatory Affairs Specialist, you will have experience working within Regulatory Affairs in the medical device industry, with a strong understanding of UK MDR, EU MDR, UKCA and ISO 13485. You will have hands-on experience preparing technical documentation and supporting regulatory compliance activities within a regulated environment.

Key Responsibilities

• Support the implementation and continual improvement of the Quality Management System in line with ISO 13485
• Prepare, review and maintain Technical Files, Design Dossiers and GSPR checklists in accordance with UK MDR and EU MDR requirements
• Support the preparation and maintenance of regulatory compliance documentation across the product portfolio
• Prepare risk management documentation and Clinical Evaluation Reports
• Coordinate Post Market Surveillance and Post Market Clinical Follow-up activities

Experience and Skills Required

• Proven Regulatory Affairs experience within the medical device industry
• Strong working knowledge of UK MDR, EU MDR 2017/745, UKCA and ISO 13485
• Experience preparing and maintaining Technical Files and regulatory documentation
• Experience supporting regulatory submissions and compliance activities
• Experience working with Class I and Class IIa medical devices
• Degree in Life Sciences, Engineering, Biomedical Science or a related discipline

If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now.

Cure Talent are delighted to be partnered with a growing medical device manufacturer with a broad and diverse product portfolio across areas including IV therapy, diabetes care, surgical, anaesthesia and consumer health. Following continued expansion, they are now looking to add another Regulatory Affairs Specialist to their Quality & Regulatory team click apply for full job details

Regulatory Affairs Specialist

Salary: £30,000 £35,000 DOE plus benefits

Location: Bedford

Full-Time; 12-month Fixed Term Contract

The Vacancy

Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between Procter and Gamble (P&G) and Abbott, and our brand Clearblue, is recognised the world over as providing accurate home pregnancy and fertility monitoring tests.

We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs team on a full-time, 12-month fixed term contract.

The role will be based at our Innovation Centre in Bedford, UK with option for hybrid working.

The Regulatory Affairs Specialist role provides technical support for the Regulatory Affairs Department, ensuring regulatory elements of international distribution of SPD Swiss Precision Diagnostics GmbH (SPD) products, and implementation of changes to products in production are fulfilled.

This role supports validation of product claims on a market specific basis and makes sure up to date documentation is available for all marketed products. The role holder will perform regulatory reviews of complaints for reportability, and report as necessary.

We re looking for someone who holds a minimum of BSc Degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.) and has comprehensive working knowledge of CE marking requirements for in vitro diagnostic medical devices or medical devices, and knowledge of international regulations for medical devices. Experience of working with Notified Bodies and Regulatory Agencies is also desirable, and an R&D background would be beneficial.

The role holder will be expected to represent the company to the highest professional standards so good interpersonal skills and excellent written and oral communication skills are essential along with the ability to communicate complex technical information clearly.

We Can Offer You:

• Hybrid working.
• Annual discretionary bonus.
• 25 days paid annual leave plus bank holidays.
• Company pension scheme including competitive employer s contribution.
• Private Medical Insurance package with additional medical cash plan scheme.
• Enhanced maternity and paternity pay.
• Company supported employee Health and Wellbeing programme.
• Life assurance.
• Free electrical car charging points.
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and rail).

If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help.

We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.

The Company

Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products.

Our SPD research centre is at the cutting edge of innovation and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.

Interested

Click apply and you will be redirected to our careers page to complete your application.

Cure Talent are delighted to be partnered with a global medical device organisation recognised as one of the most established and successful healthcare companies in the world. With a diverse international footprint and a strong pipeline of innovation, the business continues to invest heavily in next-generation technologies and regulatory excellence.

We have an opportunity for a Regulatory Affairs Manager to lead the EU Regulatory Strategy for a brand new Class III medical device. This is a strategically significant role within a highly experienced global regulatory function.

As the Regulatory Affairs Manager, you will define and drive the EU regulatory pathway under MDR 2017/745 for a new product programme. You will lead regulatory strategy development from early-stage development through to submission and approval, ensuring alignment with global regulatory, clinical and R&D teams.

This position is centred on regulatory project leadership rather than line management. While there is no direct people management initially, the scope and visibility of the programme offers long-term progression potential.

To be successful as the new Regulatory Affairs Manager, you will bring proven experience leading EU regulatory strategy for Class III medical devices, ideally within a structured global organisation. You will be confident defining approval pathways under MDR 2017/745, comfortable operating at project leadership level across R&D, Clinical and global Regulatory teams, and experienced in managing Notified Body interactions. You will combine technical depth with the ability to influence stakeholders, manage complex timelines and take ownership of a high-visibility regulatory programme from concept through to approval.

Key Responsibilities

• Define and own the EU regulatory strategy for a new Class III device under MDR.
• Lead regulatory project management activities, integrating with global RA, Clinical Affairs and R&D teams.
• Develop and maintain regulatory plans aligned to product development milestones.
• Lead Notified Body strategy and manage regulatory interactions.
• Provide regulatory input into design, risk management, clinical strategy and technical documentation.
• Support audits and ensure ongoing compliance with ISO 13485 and applicable regulations.

Experience and Skills Required

• Proven experience within Regulatory Affairs in medical devices.
• Direct experience with Class III devices is essential.
• Demonstrated leadership of regulatory strategy for new product development programmes is essential.
• Strong working knowledge of EU MDR 2017/745 and associated regulatory frameworks.
• Experience interacting with Notified Bodies and Competent Authorities.
• Experience across additional regions such as US or other international markets is highly desirable but not essential.
• Degree in a relevant scientific or engineering discipline.

This is a high-impact opportunity within a globally recognised organisation where regulatory strategy sits at the heart of product success. It will suit a regulatory professional who enjoys ownership, structured project delivery and operating within a large, well-resourced international environment.

If you would like to discuss this opportunity in confidence, we would welcome a conversation.

Regulatory Affairs Officer

Salary: £25,000 £29,000 DOE plus benefits

Location: Bedford

Full-Time, Permanent

The Vacancy

Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between Procter and Gamble (P&G) and Abbott; and our brand Clearblue, is recognised the world over as providing accurate home pregnancy and fertility monitoring tests.

We are looking for a Regulatory Affairs Officer to join our Regulatory Affairs team on a full-time, permanent basis.

The role will be based at our Innovation Centre in Bedford, UK with option for hybrid working.

This is an excellent opportunity for someone looking to take their first steps into working within a Regulatory Affairs department. The role will include both administrative tasks as well as preparation of documents to support regulatory initiatives within the department.

We re looking for someone who is highly literate and numerate with a keen eye for detail and a passion for accuracy in written work. Applicants will have the ability to engage effectively with a range of stakeholders, both within and outside the organisation, and be able to demonstrate this. The role holder will be expected to represent the company to the highest professional standards so good interpersonal skills and excellent written and oral communication skills are essential.

Previous experience in the handling of sensitive and confidential information is essential along with the understanding of the need for current Quality System / GMP / ISO compliance. Having a high level of IT literacy is essential and the ability to use standard and bespoke software applications would be advantageous.

We Can Offer You:

• Hybrid working.
• Annual discretionary bonus.
• 25 days paid annual leave plus bank holidays.
• Company pension scheme including competitive employer s contribution.
• Private Medical Insurance package with additional medical cash plan scheme.
• Enhanced maternity and paternity pay.
• Company supported employee Health and Wellbeing programme.
• Life assurance.
• Free electrical car charging points.
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and rail).

If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help.

We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.

The Company

Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products.

Our SPD research centre is at the cutting edge of innovation and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.

Interested

Click apply and you will be redirected to our careers page to complete your application.

Regulatory Affairs Manager EU, clinical trials, post approval
Your new company
An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join a leading global biotechnology organisation. Working within the European Regulatory Affairs team, you will play a critical role in supporting the development, approval and life cycle management of innovative medicines across a diverse portfolio spanning metabolic, cardiovascular, inflammatory, endocrine and bone diseases, as well as biosimilars.This role offers the opportunity to work on products from early clinical development through to marketing authorisation and post-approval activities, collaborating with cross-functional teams across Europe and globally.

Your new role
As a key member of the Regulatory Affairs function, you will be responsible for supporting regional regulatory strategies and ensuring the successful planning and execution of regulatory submissions in line with business objectives and evolving regulatory requirements.Key Responsibilities

• Plan, prepare and manage regulatory submissions, including clinical trial applications and marketing authorisation activities.
• Support the implementation of regional regulatory strategies across a portfolio of development and commercial products.
• Provide regulatory expertise and guidance to cross-functional teams on European regulatory requirements and pathways.
• Contribute to the development of regulatory documentation and support interactions with health authorities.
• Advise on regulatory mechanisms that can accelerate product development, including orphan designation, fast track pathways, paediatric plans and compassionate use programmes.
• Support labelling activities and negotiations with regulatory agencies.
• Assess regulatory risks and opportunities, helping to shape product development and life cycle strategies.
• Monitor changes in legislation, guidelines and regulatory policy, evaluating their impact on product development and commercialisation.
• Conduct regulatory research and analyse precedent cases to support strategic decision-making.
• Track competitor activities and regulatory trends within the therapeutic landscape.

What you'll need to succeed
We are seeking an ambitious and motivated Regulatory Affairs professional with:Essential Requirements

• Degree in a scientific discipline, Life Sciences or related field.
• Previous experience within Regulatory Affairs in the pharmaceutical or biotechnology industry.
• Strong understanding of European regulatory procedures for clinical trials and marketing authorisations.
• Knowledge of medicinal product legislation and regulatory guidelines.
• Understanding of drug development and product life cycle management.
• Experience working within a regional regulatory environment.
• Excellent written and verbal communication skills.
• Ability to interpret and communicate complex scientific and clinical information.
• Strong problem-solving skills with the ability to identify risks and develop effective solutions.
• Proven ability to build positive relationships and influence stakeholders across functions.

What you'll get in return
Remote working with once per month onsite presence

What you need to do now

• Join a world-leading biotechnology organisation with a strong pipeline of innovative therapies.
• Work on cutting-edge products that improve patient outcomes globally.
• Gain exposure to a broad range of regulatory activities across development and commercial portfolios.
• Collaborate with highly skilled international teams in a supportive and inclusive environment.
• Enjoy excellent career development opportunities within a global organisation.

If you are a Regulatory Affairs professional looking to take the next step in your career and contribute to bringing innovative medicines to patients across Europe, we would love to hear from you

Job Title: Regulatory Affairs Graduate

Job Type: 12 Months Fixed Term Contract

Employment Start Date: ASAP

Hours of work: Mon - Fri (37.5 hours a week)

Onsite requirement: This will be a hybrid role, with at least 3 days per week on site

Industry: Pharmaceuticals

Location: Bracknell, UK

Salary: 30.000 per annum; holidays, sick pay, pension

An excellent opportunity for a talented graduate to start a career in regulatory affairs with a global healthcare organisation, our client is a market leader specialising in the development of generic and biosimilar medicines.

Job Purpose

This role supports pre- and post-approval regulatory activities to ensure compliance while meeting business needs. Responsibilities include regulatory submissions, labelling and SmPC updates, stakeholder communication, audit support, archive maintenance, and monitoring departmental projects in line with KPIs, while adhering to global and local SOPs and working instructions.

Your responsibilities will include, but are not limited to:

• Preparation and submission of the following:
  • Marketing Authorisation variation and renewal applications
  • Labelling update applications under Article 61(3)
  • Change of ownership applications
  • Licence cancellations
• Creation, assessment and approval of labelling artwork texts and mock-ups.
• Reviewing and updating Summaries of Product Characteristics.
• The processing and clear communication of regulatory approvals to internal and external stakeholders.
• Monitoring and supporting departmental projects in line with KPIs.
• Working in accordance with Global and local Working Instructions and SOPs.
• Maintenance of regulatory archives.
• Provision of regulatory support for internal and external audits.
• Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department.

Skills & Experience:

To be considered for the Regulatory Affairs Graduate, you'll need the following skills and experience:

• Recently graduated from a UK university within the last 2 years, with a BSc in Life Sciences.
• Ability to be flexible and multi-task within a fast-paced environment.
• Experience in Regulatory Affairs within a Generic or Pharma business (desirable)

• Has an understanding of regulatory maintenance processes.

• Can effectively cope with change in a fast-moving business.
• Ability to demonstrate transferable skills to the business environment, such as good time management and teamwork, through previous work experience, academic achievements, or extracurricular activities.
• Strong prioritisation skills, with the ability to effectively manage multiple priorities and demonstrate attention to detail, even under tight deadlines.
• Collaborative mindset, with the ability to develop effective relationships with team members and customers, gaining trust and credibility quickly. You should be comfortable working with people of all levels and backgrounds as a valuable member of a cross-functional team.
• IT proficiency and highly proficient in Microsoft Office suite (Outlook, Excel, PowerPoint, and Word).
• Fluency in English - Verbal and Written

The successful candidate will benefit from:

• Team oriented atmosphere
• Cutting edge science
• Working with diverse people and teams
• Development opportunities
• Making a difference to patient's lives

Additional Information

Please ensure that you are willing and able to live within commutable distance of the company site before applying. This placement is based in their Bracknell, UK offices, and you will be required to be in the office a minimum of 12 days per month, to aid your development in working with and learning from your team. You will need to be eligible to work in the United Kingdom.

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.

Your new company
Our client, a global biotechnology company focused on developing innovative therapies for rare and serious diseases, is seeking an experienced Regulatory Affairs CMC Manager to join their EU Regulatory team.This is an excellent opportunity to contribute to cutting-edge biologics and advanced therapies, supporting global post-approval strategies and new market applications across both EU and US regions.

Your new role
Reporting to the Senior Director, Regulatory Affairs CMC (EU), you will play a key role in delivering global regulatory CMC strategies for commercial products. You'll collaborate with international teams across Europe and the US to ensure successful execution of regulatory submissions and lifecycle activities.

• Act as the Regulatory CMC representative at site and cross-functional meetings, providing clear regulatory guidance.
• Lead the planning, coordination, and compilation of high-quality CMC documentation for global post-approval submissions
• Ensure all submissions comply with relevant regulatory requirements and guidelines (EU, FDA, and global standards)
• Partner with international teams to support change controls and GMP documentation
• Contribute to global product registrations, renewals, and lifecycle management
• Identify potential risks and proactively develop mitigation strategies
• Support interactions with global regulatory authorities
• Maintain strong collaboration across regulatory, technical, and operational teams

What you'll need to succeed

• Strong experience in Regulatory Affairs CMC, ideally within biologics, biotechnology, or advanced therapies
• Demonstrated experience with post-approval submissions and lifecycle management
• Significant FDA experience is essential, alongside a solid understanding of EU regulations.
• Proven ability to manage complex projects and global stakeholders
• Excellent communication and organisational skills

What you'll get in return
Flexible working options available.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

Manager - Regulatory Affairs Submission Management

Contract: Temporary - 12 months (extension possible)
Location: Maidenhead - hybrid working (or remote if needed)
Rate: (INSIDE IR35)
- circa. 22-25 per hour (PAYE)

SRG are seeking a Regulatory Affairs professional with Submission Management skills & experience to assist a leading pharmaceutical company on a temporary basis. Join a dynamic regulatory affairs team and play a pivotal role in delivering complex regulatory submissions that support the development, approval, and life-cycle management of innovative healthcare products.

Key Responsibilities

• Lead and manage complex regulatory submission projects, ensuring high-quality dossiers are delivered on time and in line with regulatory requirements.
• Act as the primary regulatory submission management contact for cross-functional project teams, providing guidance on processes, timelines, and deliverables.
• Coordinate and facilitate submission planning meetings, driving progress across multiple concurrent projects and stakeholders.
• Oversee publishing activities and collaborate with external publishing partners to ensure successful submission delivery.
• Perform quality reviews of published submissions, ensuring compliance with technical standards and regulatory authority requirements.
• Contribute to continuous improvement initiatives, enhancing regulatory processes, standards, and systems.

Skills & Experience Required

• Bachelor's degree or equivalent combination of education and relevant industry experience.
• Experience within the pharmaceutical, biotechnology, healthcare, or related regulated industry.
• Strong project management skills, with experience managing complex, cross-functional activities and competing priorities.
• Knowledge of regulatory operations, submission management, and/or submission publishing processes.
• Excellent written and verbal communication skills, with the ability to influence stakeholders in a matrix environment.
• Demonstrated leadership capability, including mentoring colleagues and driving process improvements. PMP and/or RAC certification is advantageous.

To Apply

Please click and submit your profile and/or to discuss further, contact Theo Charles on (phone number removed)

Umbrella also possible - please enquire for more information

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.