Regulatory Lead, Medical Devices

3 weeks ago


Cambridgeshire, United Kingdom The One Group Full time

New
- Location: Cambridgeshire
- Salary: Negotiable per year
- Job Type:Permanent

Posted about 2 hours ago
- **Sector**: Technical & Engineering Recruitment
- **Contact**: Jen Richardson
- **Expiry Date**: 14 May 2023
- **Job Ref**: BBBH46938_1681451692

The ONE Group have been partnering with this company for a number of years and have always been impressed that a relatively small company could do such BIG things with medical devices

Based in pretty, rural Cambridgeshire, on the A1 corridor, not far from St Neots, this organisation are specialists in remote health and well-being monitoring, via a sleek wearable device and associated software. Another part of the business provides innovative preventative oral care and infection control technologies. A real mix of Class 1 and Class 2a medical devices

Due to company growth, the **Regulatory Lead **will manage compliance across the company's portfolio. This will be a varied position working across several different product ranges with varying customers and standards. Initially there will be an element of QMS Management and ensuring ISO:13485 standards are adhered to. However, the role will evolve over time and be completely focused on regulatory compliance.

**The Role**:

- Lead the company's Regulatory Affairs and Quality Assurance function and strategy, including product registration, complaint handling & reporting and internal and external audits
- Be the operational medical device regulatory affairs "go-to" person for the company, providing advice to other departments
- Coordinate inspection of the organisation and contract facilities and develop procedures to ensure regulatory compliance
- Ensure compliance with regulations set by MHRA
- Plan, undertake and oversee trials and regulatory inspections
- Outline requirements for labelling, storage and packaging
- Develop, review, update and implement regulatory strategy
- Risk assessments
- Provide a high level of customer service as first point of contact with externals on technical queries, complaints, recalls/FSCA, vigilance including post-marketing surveillance and quality issues for medical devices and pharmaceuticals

**About You**:

- Degree in a scientific or related field
- Significant proven leadership experience of Regulatory Affairs within the medical devices and pharma industry
- Extensive knowledge of regulatory requirements (MDD, MDR)
- Ability to independently develop regulatory strategies
- QA/RA experience in a regulated environment (e.g., ISO 13485:2016)
- Ability to drive standards

The position is most likely to be based on-site, although there may be the opportunity for some remote work and flexibility. Hours are 9am to 5pm Monday to Friday. Holiday starts at 20 days per year, rising to 23 days after 2 years and 25 days after 3 years. There is a generous company pension scheme. This is a small company where many of the team have worked for years. Salary will be dependent on your experience and what you can offer the role and organisation.

Looking forward to hearing from you


  • Head of Quality

    1 week ago


    Cambridge, Cambridgeshire, United Kingdom RRxCo.™ Full time

    RRxCo is partnered with a leading Life Science Manufacturer in the search for a UK Head of Quality to support significant growth. You will lead Quality advances across their team of 400 colleagues, build a dedicated Quality team in the United Kingdom (UK), and grow a culture of world-class quality. Develop, implement and manage the Quality system and...


  • Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto injector)...


  • Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto injector)...

  • Head of Quality

    2 weeks ago


    Cambridge, Cambridgeshire, United Kingdom RRxCo.™ Full time

    Job Description RRxCo is partnered with a leading Life Science Manufacturer in the search for a UK Head of Quality to support significant growth. You will lead Quality advances across their team of 400 colleagues, build a dedicated Quality team in the United Kingdom (UK), and grow a culture of world-class quality. Develop, implement and manage the...


  • Cambridgeshire, United Kingdom Vector Recruitment Limited Full time

    Project Lead (Healthcare) Cambridgeshire £60k-£70k + excellent benefits We are looking for an exceptional hands-on Project Leader to join an expanding, highly professional, technical R&D consultancy developing new products on behalf of external clients - specifically within their Healthcare department. They work heavily with novel medical devices as well...

  • Validation Engineer

    2 months ago


    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Validation Engineer - Medical Devices A growing medical devices company based in Cambridgeshire are in the process of expansion and are actively looking for an experienced Validation Engineer to join the team. The role as Validation Engineer will give you the opportunity to work on novel and complex medical devices whilst working closely with R&D...

  • Validation Engineer

    2 months ago


    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Validation Engineer - Medical Devices A growing medical devices company based in Cambridgeshire are in the process of expansion and are actively looking for an experienced Validation Engineer to join the team. The role as Validation Engineer will give you the opportunity to work on novel and complex medical devices whilst working closely with R&D...


  • Cambridgeshire, United Kingdom Vector Recruitment Full time

    Head of Product Development – Implantable Medical DevicesCambridgeshire£140k-£150k (dep on exp) + bonus and excellent benefits!  A brand-new opportunity has arisen for a Head of Product Development for Implantable medical devices to join a leading R&D technology development company based in Cambridgeshire – to head up their new Neurotech department....

  • Electronics Engineer

    2 months ago


    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Electronics Engineer - Cancer Instrumentation - Cambridge A growing Medical Devices Division is currently seeking an Electronics Engineer to contribute to the development of new Cancer Instrumentation devices, based in South Cambridge. You will work on a wide range of electronics design tasks, including, but not limited to, power electronics,...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Mechanical Engineer - Cancer Instrumentation - Cambridge A growing division within an established Medical Devices organisation in South Cambridge is currently seeking an experienced Medical Devices Mechanical Engineer to contribute to their ongoing development of cutting-edge cancer instrumentation, aimed at improving patient recovery rates. This...

  • Medical Device Lead

    7 days ago


    Cambridge, Cambridgeshire, United Kingdom Vantage Talent Solutions Full time €100,000 - €150,000

    Program Manager (NeuroTech) (Active Implants) Location: Cambridge (Hybrid) Salary: £100k - £150k Relocation Package available! Want to join one of the UK’s most successful consultancies? Do you feel passionate about Medical Devices and embedding yourself in an innovate industry? Do you want to be apart of ground breaking technology? Well this role...

  • Medical Device Lead

    7 days ago


    Cambridge, Cambridgeshire, United Kingdom Vantage Talent Solutions Full time €100,000 - €150,000

    Program Manager (NeuroTech) (Active Implants) Location: Cambridge (Hybrid) Salary: £100k - £150k Relocation Package available! Want to join one of the UK’s most successful consultancies? Do you feel passionate about Medical Devices and embedding yourself in an innovate industry? Do you want to be apart of ground breaking technology? Well this role...

  • Medical Device Lead

    7 days ago


    Cambridge, Cambridgeshire, United Kingdom Vantage Talent Solutions Full time €100,000 - €150,000

    Job Description Program Manager (NeuroTech) (Active Implants) Location: Cambridge (Hybrid) Salary: £100k - £150k Relocation Package available! Want to join one of the UK’s most successful consultancies? Do you feel passionate about Medical Devices and embedding yourself in an innovate industry? Do you want to be apart of ground breaking technology?...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Junior Verification Engineer - Medical Devices A growing medical devices company based in Cambridgeshire are in the process of expansion and are actively looking for a Verification Engineer to join the team. The role as Verification Engineer will give you the opportunity to work on novel and complex medical devices whilst working closely with R&D...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Medical Devices Mechanical Engineer - SolidWorks - Cambridge A growing Medical Devices group is currently seeking a Mechanical Design Engineer to assist in the development of life-saving Medical Devices. Based in South Cambridgeshire, you will utilize SolidWorks for the CAD design of new Medical Devices. You will collaborate with inventors,...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Electronics Design Engineer - Medical Devices FPGA - Cambridge An exciting and growing Medical Devices organization based in Cambridge is currently seeking an experienced Electronics Design Engineer to work on the development of life-saving and life-improving Medical Devices. With a primary focus on FPGA design, you will collaborate with other...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Medical Devices Consultant - Senior Mechanical Engineer - Cambridge Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role. The company is based in Cambridge and boasts some of the most impressive...


  • South Cambridgeshire, Cambridgeshire, United Kingdom SoCode Limited Full time

    Are you an experienced Electronics Engineer, looking to work on medical devices that can rapidly and safely diagnose the spread of Flu, Covid, Strep, STI’s and more? Created during the height of the pandemic in 2020, this business was born to help the world when it needed it most. You can be a key part in getting this product to market, utilising your...


  • South Cambridgeshire, Cambridgeshire, United Kingdom SoCode Limited Full time

    Are you an experienced Electronics Engineer, looking to work on medical devices that can rapidly and safely diagnose the spread of Flu, Covid, Strep, STI’s and more? Created during the height of the pandemic in 2020, this business was born to help the world when it needed it most. You can be a key part in getting this product to market, utilising your...


  • Cambridge, Cambridgeshire, United Kingdom SoCode Recruitment Full time

    Are you an experienced Electronics Engineer, looking to work on medical devices that can rapidly and safely diagnose the spread of Flu, Covid, Strep, STI’s and more? Created during the height of the pandemic in 2020, this business was born to help the world when it needed it most. You can be a key part in getting this product to market, utilising your...