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Quality Assurance & Regulatory Affairs Specialist - MedTech
A growing medical devices company in Cambridgeshire are currently in need of an experienced quality assurance and regulatory affairs specialist.
This is an excellent opportunity for a QARA specialist to join this team of experts and work on highly complex medical technology, across multiple territories and product ranges.
This is a key role in the development of lifesaving and life-improving medical devices, ensuring compliance, assurance, and regulatory best practice across the entire design and manufacturing process on products and services that will be launched in Europe, North America, and the APAC region.
This company have a proven track record of delivering step-changes in technology through innovation and intricate design, and you will fit right in if you have a sharp eye for detail and enjoy working in an environment that prioritises autonomy and responsibility.
To be successful in this role you will need to have knowledge of quality assurance and regulatory standards within the UK and Europe. So, in-depth knowledge of ISO 13485, CE Marking, and other standards will be essential. This role will give you the chance to shape their strategy and processes while providing great opportunities for growth and development.
Undertaking internal audits will be important in this role so hopefully you have experience of this in your current role.
To complement your experience, we are looking for candidates that have an engineering or biomedical engineering background, ideally to a minimum of a bachelor's degree. The client is open-minded on this so we are also considering candidates from a scientific background. The ideal experience level will be from 2-to-5 years, but this is open for the right candidate.
You will be rewarded with a challenging role that you will never get bored with. As new medical devices are being developed all the time you will always be working on something new rather than managing pre-existing regulatory affairs documentation.
The company are offering a strong package on this role, depending on your overall experience, which includes a performance bonus, pension, free lunches, and a variety of other benefits too.
Please note that they are ideally looking for someone to be based fulltime in the office.
If you would like to find out more about the company and this role then go ahead and make a confidential application and a member of our team will be in touch with more details.
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About the Role
We are seeking an experienced Senior Regulatory Affairs Specialist to join a SME Medical Device company. This is a key role responsible for ensuring our medical devices meet global regulatory requirements and maintain compliance across all markets.You'll play a pivotal role in supporting product registrations, maintaining technical documentation, and working closely with cross-functional teams to ensure regulatory excellence throughout the product lifecycle.
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.
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:
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
Experience and Skills Required
If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now.
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.
They are looking for a Regulatory Affairs Specialist to join their Regulatory Affairs team on a full-time, 12-month fixed term contract.
The role will be based at their 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 our client's 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.
Our client is 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.
Our Client Can Offer You:
If you require any reasonable adjustments to support you, at any stage during the application process, just let our client know how they can help.
They are an equal opportunity employer and value diversity. They do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.
The Company
Our client is a world leader in the research, design and marketing of advanced consumer diagnostic products.
Their 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. They are committed to answering the needs of their existing and future consumers, through a continuous flow of new and innovative products.
Interested
Click apply and you will be redirected to our client's careers page to complete your application.
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
The Lead Quality Assurance Specialist role is a key technical leadership position supporting GMP compliance, CAPA processes, and continuous improvement initiatives within the QA environment. The successful candidate will oversee the electronic Quality Management System, provide governance and oversight of deviations, investigations, and change controls, and mentor the QA team in developing robust quality processes. They will also lead internal audits, develop quality metrics, and contribute to inspection readiness, ensuring that GMP standards are maintained and improved through a pragmatic, risk-based approach.
Offering a highly competitive benefits package, the company provides 33 days holiday (including public holidays), private health cover, a contributory pension scheme, life assurance, and a Christmas bonus equivalent to two weeks pay. Additional benefits include profit share bonuses, wellbeing programs, and sick pay, making this an excellent opportunity for an experienced GMP QA professional to develop their career within a supportive and rewarding environment.
Care & Quality Assurance Manager - Specialist Services
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Care & Quality Assurance Manager- Specialist Services
PURPOSE OF POST: To work as part of a team providing high-quality care and support to Clients to remain indepen click apply for full job details
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
Experience and Skills Required
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:
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.
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