Regulatory Lead, Medical Devices

2 months ago

St Neots, United Kingdom The One Group Full time

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 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 innovativepreventative 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 bean 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

  • Quality and Regulatory Manager

    1 month ago

    St. Albans, United Kingdom ProTech Recruitment Ltd Full time

    Quality & Regulatory Manager Industry: Medical Devices Salary & Benefits: £45,000 - £55,000 + bonus and benefits package Location: Hertfordshire A great opportunity has arisen for a Quality and Regulatory Manager for a leading Medical Device company based near St Albans, Hertforsdhire. The Quality and Regulatory Manager role will be responsible for...

  • Medical Device Project Engineer

    1 month ago

    Bury St Edmunds, United Kingdom Serve Talent Full time

    Job Title: Medical Device Project Engineer Location: Suffolk, UK Are you an experienced and driven Medical Device Project Engineer seeking a new and exciting opportunity? We are working with a dynamic and innovative company based in Suffolk, looking to expand their team with a talented individual who possesses a strong background in manufacturing medical...

  • Laboratory Technician

    1 week ago

    St Helens, United Kingdom People & Process Solutions Int. Ltd Full time

    Visa sponsorship is not available for this role. Please do not apply if you havent got the extended rights to work in the UKIf your skills, experience, and qualifications match those in this job overview, do not delay your application.Job Summary:My client is a market leading manufacturer of electro-mechanical medical equipment and devices. Due to growth...

  • Laboratory Technician

    2 weeks ago

    St Helens, United Kingdom People & Process Solutions Int. Ltd Full time

    Visa sponsorship is not available for this role. Please do not apply if you havent got the extended rights to work in the UKJob Summary:My client is a market leading manufacturer of electro-mechanical medical equipment and devices. Due to growth they need to strengthen their lab team.Duties:Work on product validation activities including new and existing...

  • Laboratory Technician

    2 weeks ago

    St Helens, United Kingdom People & Process Solutions Int. Ltd Full time

    Visa sponsorship is not available for this role. Please do not apply if you havent got the extended rights to work in the UKJob Summary:My client is a market leading manufacturer of electro-mechanical medical equipment and devices. Due to growth they need to strengthen their lab team.Duties:Work on product validation activities including new and existing...

  • Laboratory Technician

    2 weeks ago

    St Helens, United Kingdom People & Process Solutions Int. Ltd Full time

    Visa sponsorship is not available for this role. Please do not apply if you havent got the extended rights to work in the UK Job Summary: My client is a market leading manufacturer of electro-mechanical medical equipment and devices . Due to growth they need to strengthen their lab team. Duties: Work on product validation activities including new and...

  • Laboratory Technician

    2 weeks ago

    St Helens, United Kingdom People & Process Solutions Int. Ltd Full time

    Visa sponsorship is not available for this role. Please do not apply if you havent got the extended rights to work in the UKJob Summary:My client is a market leading manufacturer of electro-mechanical medical equipment and devices. Due to growth they need to strengthen their lab team.Duties:Work on product validation activities including new and existing...

  • Laboratory Technician

    1 week ago

    St. Helens, Merseyside, United Kingdom People & Process Solutions Int. Ltd Full time

    Visa sponsorship is not available for this role. Please do not apply if you havent got the extended rights to work in the UK Job Summary: My client is a market leading manufacturer of  electro-mechanical medical equipment and devices . Due to growth they need to strengthen their lab team. Duties: Work on product validation activities including new and...

  • Laboratory Technician

    2 weeks ago

    St. Helens, Merseyside, United Kingdom People & Process Solutions Int. Ltd Full time

    Visa sponsorship is not available for this role. Please do not apply if you havent got the extended rights to work in the UK Job Summary: My client is a market leading manufacturer of  electro-mechanical medical equipment and devices . Due to growth they need to strengthen their lab team. Duties: Work on product validation activities including new and...

  • Regulatory, QMS

    2 weeks ago

    St Neots, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System.The full job description covers all associated skills, previous experience, and any...

  • Regulatory, QMS

    2 weeks ago

    St. Neots, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System.Operating in an environment with high regulatory requirements, they contribute to the...

  • Regulatory, QMS

    4 weeks ago

    St Neots, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System.Operating in an environment with high regulatory requirements, they contribute to the...

  • Regulatory, QMS

    4 weeks ago

    St Neots, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System.Operating in an environment with high regulatory requirements, they contribute to the...

  • Regulatory, QMS

    4 days ago

    St. Neots, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System.Operating in an environment with high regulatory requirements, they contribute to...

  • Regulatory, QMS

    4 weeks ago

    St Neots, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System. Operating in an environment with high regulatory requirements, they contribute to the...

  • Regulatory, QMS

    4 weeks ago

    St Neots, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System.Operating in an environment with high regulatory requirements, they contribute to the...

  • Regulatory, QMS

    4 weeks ago

    St Neots, Cambridgeshire, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System. Operating in an environment with high regulatory requirements, they contribute to...

  • Regulatory, QMS

    3 days ago

    St Neots, UK, Cambridgeshire, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System.Operating in an environment with high regulatory requirements, they contribute to...

  • Regulatory, QMS

    4 weeks ago

    St Neots, Cambridgeshire, United Kingdom Ennov Full time

    Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System. Operating in an environment with high regulatory requirements, they contribute to...

  • Electronics Design Engineer

    1 week ago

    St Albans, Hertfordshire, United Kingdom Octagon Group Full time

    An exciting opportunity is available for an Electronics Design Engineer to join a small R&D team based in Harpenden, Hertfordshire! You will be working on consultancy-based projects and will be a key member of the development team, working on the design of exciting products for a wide range of applications including medical devices, wearables and the...