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Regulatory Affairs Coordinator

Hertford

Hybrid/Part-Time Working Available

Up to 40,000

An established manufacturer of regulated products is seeking a Regulatory Affairs Coordinator to support the ongoing maintenance of compliance and technical documentation across an established portfolio of products.

This is a hands-on role suited to someone who enjoys practical regulatory work within an SME environment and can efficiently manage documentation and compliance activities without unnecessary complexity.

• Maintain UK and EU product registrations.
• Review and maintain Technical Files and supporting documentation.
• Prepare and maintain PMS, PSUR and Clinical Evaluation documentation.
• Review and update IFUs and product labelling.
• Monitor regulatory updates and ensure ongoing compliance.
• Prepare technical justifications, gap analyses and briefing notes.
• Support customer regulatory queries and external audits.
• Maintain electronic and physical document control systems.

• Previous experience within medical devices, regulatory affairs or quality assurance.
• Knowledge of ISO13485 and medical device regulations including MDR, MDD and UKCA.
• Experience with Technical Files and technical documentation.
• Strong organisational skills and attention to detail.
• Comfortable working independently within an SME environment.

Unfortunately, sponsorship is not available for this position, so applicants must already hold full and unrestricted right to work in the UK.

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.

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.

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 Specialist

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

Location: Bedford

Full-Time; 12-month Fixed Term Contract

The Vacancy

Our client is a world leader in the research, design and supply of advanced consumer diagnostic products. They have a joint venture, and their brand is recognised the world over as providing accurate home pregnancy and fertility monitoring tests click apply for full job details

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

Temporary Medical Secretary, Little Hulton Immediate start (Ongoing)

13 - 14 per hour, Mon-Fri - 27 hours per week.

Our client is looking for an experienced Medical Secretary to support their team.

Duties will be:

• Audio typing patient letters and documents
• Answering incoming calls
• Maintaining records on EMIS
• Supporting both inpatient and outpatient departments with administrative duties
• Minute taking in meetings

Previous experience with audio typing, minute taking and using EMIS is essential for this role.

Please note that this role will involve discussing and typing sensitive content that some people may find upsetting.

Due to the high volume of applications we receive, only those successfully shortlisted for the role will be personally contacted.

Follow FORREST RECRUITMENT LTD on LinkedIn and Facebook for updates, recruitment information, new vacancies and more!

Medical Secretary Ad Hoc Holiday & Sickness Cover (Bank Staff)

We are looking to build a bank of experienced Medical Secretaries who are available to provide ad hoc holiday and sickness cover for our client, based in Epsom.

• Approximately 2 hours per day, 6 days per week
• Minimum 1 day per week onsite at their Epsom clinic
• Remaining hours can be worked remotely, where appropriate

Requirements:

• Previous experience in medical administration is essential
• Excellent organisational and communication skills
• Ability to work independently and manage confidential information
• Experience within mental health services would be advantageous

Rate of Pay:

• 15 - 20 per hour, depending on experience

This is an excellent opportunity for a flexible and reliable Medical Secretary looking for additional work on an ad hoc basis.

If this could be of interest, please send your CV and a brief summary of your availability.

Refer a friend and earn a retail voucher worth up to 500!

Unfortunately, due to high numbers of applications, we are only able to respond to shortlisted applicants. If you have not heard from us within 5 days, please assume that you have not been shortlisted on this occasion.

By applying for this vacancy, you accept Lloyd Recruitment Services Privacy and GDPR Policy which can be found on our website and therefore gives us consent to contact you.

Lloyd Recruitment Services are acting as a recruitment agency in relation to this vacancy and are an equal opportunities employer

ME15710

Are you an experienced Medical Secretary with excellent medical knowledge?

Have you used ERS and able to do medical reports and insurance?

Are you immediately available?

If you can answer yes to all of the above, Lifeline has a brilliant opportunities for you!

A welcoming NHS GP surgery is looking for a Medical Secretary to work part time Monday - Wednesday.

The ideal Medical Receptionist will:
Have at least 6 months recent experience working in NHS GP surgery as a Medical Secretary
Be confident in using ERS and Emis Web
Have Your Own Smart Card
Be happy to undergo a DBS check or have a DBS certificate dated within a year
Be flexible, reliable and professional

Lifeline Recruitment Services is a specialist NHS approved health care agency, who are the preferred supplier to a variety of GP Practices and Private Clinics all over the UK.

Here at Lifeline, we pride ourselves on our dedicated service for both candidates and clients. Our friendly staff ensure that you experience a smooth registration process, are committed to finding you the right shifts and can be easily contacted.

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If you are interested please apply for the role now,