Current jobs related to Regulatory Lead, Medical Devices - St Neots - The One Group

  • Medical Information Specialist

    1 week ago

    St Albans, Hertfordshire, United Kingdom Chase Full time

    Medical Information Manager – Aesthetics – Hertfordshire OfficeOur client, a renowned European pharmaceutical company, is seeking an accomplished Medical Information Manager to join their team. As a key member of the organization, you will be responsible for delivering high-quality medical information to external customers and internal...

  • Medical Information Specialist

    1 week ago

    St Albans, Hertfordshire, United Kingdom Chase Full time

    Medical Information Manager – Aesthetics – Hertfordshire OfficeOur client, a renowned European pharmaceutical company, is seeking an accomplished Medical Information Manager to join their team. As a key member of the organization, you will be responsible for delivering high-quality medical information to external customers and internal...

  • Device Simulation Software Developer

    2 weeks ago

    St Ives, Cornwall, United Kingdom Silvaco Full time

    Job SummarySilvaco is seeking a skilled software engineer to join our device simulation team in Europe. As a member of our TCAD group, you will design, implement, and evaluate physical models and methods for simulating semiconductor devices.Key ResponsibilitiesDevelop and maintain existing simulation softwareIdentify and improve software limitationsDevelop...

  • Device Simulation Software Developer

    2 weeks ago

    St Ives, Cornwall, United Kingdom Silvaco Full time

    Job SummarySilvaco is seeking a skilled software engineer to join our device simulation team in Europe. As a member of our TCAD group, you will design, implement, and evaluate physical models and methods for simulating semiconductor devices.Key ResponsibilitiesDevelop and maintain existing simulation softwareIdentify and improve software limitationsDevelop...

  • Project Engineer

    1 day ago

    Bury St, Suffolk, United Kingdom Elev8 Recruitment Ltd Full time

    Are you a skilled professional looking to make a meaningful impact in the medical device industry? Elev8 Recruitment Ltd is seeking a talented Project Engineer to join their innovative team.This is an exciting opportunity to be at the forefront of medical technology development, bringing life-changing devices from concept to reality.As a Project Engineer,...

  • Project Engineer

    1 day ago

    Bury St, Suffolk, United Kingdom Elev8 Recruitment Ltd Full time

    Are you a skilled professional looking to make a meaningful impact in the medical device industry? Elev8 Recruitment Ltd is seeking a talented Project Engineer to join their innovative team.This is an exciting opportunity to be at the forefront of medical technology development, bringing life-changing devices from concept to reality.As a Project Engineer,...

  • Medical Director

    3 weeks ago

    St Annes, Lancashire, United Kingdom Parcliffe Medical Centre Full time

    Job SummaryWe are seeking a highly skilled and experienced Medical Director to join our team at Parcliffe Medical Centre. As a key member of our leadership team, you will be responsible for providing high-quality patient care and leading our clinical team to deliver exceptional healthcare services.Key ResponsibilitiesClinical Leadership: Provide clinical...

  • Medical Director

    3 weeks ago

    St Annes, Lancashire, United Kingdom Parcliffe Medical Centre Full time

    Job SummaryWe are seeking a highly skilled and experienced Medical Director to join our team at Parcliffe Medical Centre. As a key member of our leadership team, you will be responsible for providing high-quality patient care and leading our clinical team to deliver exceptional healthcare services.Key ResponsibilitiesClinical Leadership: Provide clinical...

  • Project Engineer

    3 days ago

    Bury St, Suffolk, United Kingdom Elev8 Recruitment Ltd Full time

    Project EngineerElev8 Recruitment Ltd is seeking a highly skilled Project Engineer to join their innovative team. As a Project Engineer, you will be responsible for leading the development of medical devices from concept to reality.Key Responsibilities:Guide the project team and manage timelines to ensure successful project deliveryCreate and manage...

  • Project Engineer

    3 days ago

    Bury St, Suffolk, United Kingdom Elev8 Recruitment Ltd Full time

    Project EngineerElev8 Recruitment Ltd is seeking a highly skilled Project Engineer to join their innovative team. As a Project Engineer, you will be responsible for leading the development of medical devices from concept to reality.Key Responsibilities:Guide the project team and manage timelines to ensure successful project deliveryCreate and manage...

  • Medical Information Specialist

    2 weeks ago

    St Albans, Hertfordshire, United Kingdom CHASE Full time

    Medical Information Manager - AestheticsOur client, a leading European Pharmaceutical Company, is seeking an accomplished Medical Information Manager to join their Hertfordshire office. As a key member of the team, you will be responsible for delivering high-quality medical information to external customers and internal colleagues.Key Responsibilities:Ensure...

  • Medical Information Specialist

    2 weeks ago

    St Albans, Hertfordshire, United Kingdom CHASE Full time

    Medical Information Manager - AestheticsOur client, a leading European Pharmaceutical Company, is seeking an accomplished Medical Information Manager to join their Hertfordshire office. As a key member of the team, you will be responsible for delivering high-quality medical information to external customers and internal colleagues.Key Responsibilities:Ensure...

  • Graduate Medical Sales Representative

    4 months ago

    St Albans, United Kingdom Evolve Full time

    Are you a recent Science Graduate eagerly looking to kickstart your career in the medical sales industry? Look no further! We’re recruiting for an exceptional opportunity for a Graduate to become part of a renowned global leader in the Medical Device industry, who specialises in pioneering products for breast cancer surgery. Due to strong sales and...

  • Regulatory Compliance Lead

    4 weeks ago

    St Albans, United Kingdom Abacus Consulting Full time

    Position OverviewJoin Abacus Consulting as a Regulatory Compliance Lead within a thriving and privately owned financial services firm. This role offers a competitive salary of up to £65,000 and is based in St Albans.As a pivotal member of our team, you will oversee compliance and risk management, ensuring adherence to all relevant regulations, including FCA...

  • Project Engineer

    4 days ago

    Bury St, Suffolk, United Kingdom Elev8 Recruitment Ltd Full time

    Project EngineerElev8 Recruitment Ltd is seeking a highly skilled Project Engineer to join their innovative team. As a Project Engineer, you will be responsible for leading the development of medical devices from concept to reality.Key Responsibilities:Guide the project team and manage timelines to ensure successful project deliveryCreate and manage...

  • Project Engineer

    4 days ago

    Bury St, Suffolk, United Kingdom Elev8 Recruitment Ltd Full time

    Project EngineerElev8 Recruitment Ltd is seeking a highly skilled Project Engineer to join their innovative team. As a Project Engineer, you will be responsible for leading the development of medical devices from concept to reality.Key Responsibilities:Guide the project team and manage timelines to ensure successful project deliveryCreate and manage...

  • Pharmacy Procurement Lead

    3 months ago

    St Helens, United Kingdom Allied Pharmacies Full time

    Allied Pharmacies is a chain of pharmacies based on partnerships with local pharmacists. Utilizing over 50 years of combined experience within this sector we now boast a portfolio of over 170 pharmacies across the UK. We are looking for dynamic hardworking and driven Pharmacy professionals who can lead and deliver the highest quality healthcare service to...

  • Emergency Medical Tech

    3 months ago

    St Albans, United Kingdom MET Medical Full time

    Join MET Medical as an Emergency Medical Technician (EMT), as part of our frontline 999 team. Your core rota will predominantly be on our 999 contract. As a qualified EMT, you will respond to emergency calls, offer crucial medical assistance, and contribute significantly to the well-being of our patients. This role is not only personally rewarding but also...

  • Quantum Device Software Developer

    1 week ago

    St Ives, Cornwall, United Kingdom Silvaco Full time

    Job SummarySilvaco is seeking a skilled software engineer to join our device simulation team in Europe. As a member of the TCAD group, you will design, implement, and improve quantum mechanical physical models and methods for the simulation of semiconductor devices.Key ResponsibilitiesDevelop, support, test, and maintain simulation software tools.Identify...

  • Quantum Device Software Developer

    7 days ago

    St Ives, Cornwall, United Kingdom Silvaco Full time

    Job SummarySilvaco is seeking a skilled software engineer to join our device simulation team in Europe. As a member of the TCAD group, you will design, implement, and improve quantum mechanical physical models and methods for the simulation of semiconductor devices.Key ResponsibilitiesDevelop, support, test, and maintain simulation software tools.Identify...

Regulatory Lead, Medical Devices

4 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