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Regulatory Lead, Medical Devices

The One Group
Job LocationSt. Neots
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

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 companys 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 companys Regulatory Affairs and Quality Assurance function and strategy, including product registration, complaint handling & reporting and internal and external audits
  • Oversee the approvals process, including filing necessary applications and handling all government interactions
  • 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!

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