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Regulatory Affairs Manager

Thomas Lee Recruitment
Job LocationLeeds
EducationNot Mentioned
Salary£45,000 - £50,000 per annum, negotiable, inc benef
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Are you an experienced regulatory professional within medical devices We are seeking an experienced regulatory manager to join a Times Top 100 employer, implantable medical devices company based in Leeds. You would be reporting to a compliance director and managing a headcount of four.KEY RESPONSIBILITIES:

  1. Act as back-up/deputy PRCC in lieu of Compliance Director.
  2. Generate Technical Files for new products.
  3. Update technical files as a result of changes to products or regulations, such as MDR, and ensure that CE marking is maintained.
  4. Conduct distributor approval.
  5. Conduct registration in new markets including MDSAP.
  6. Undertake Regulatory submissions including 510(k) for the United States.
  7. Prepare for and attend regulatory audits.
  8. Support the complaints function of the Quality team with regard to regulatory reporting and vigilance.
9. Provide line management support, direction and coaching to the regulatory team and conduct regular catch-ups and annual Staff Development Reviews.10. Undertake any other duties of a regulatory nature including attending cross-company meetings and providing advice to other departments.Essential Experience, Knowledge and Qualifications
  • Degree in a scientific subject, preferably biology or chemistry or bioengineering.
  • Regulatory experience in in a medical device company dealing with implantable devices.
  • Experience supporting distributor approval in a medical device company.
    • Desirable Experience, Knowledge and Qualifications
  • Higher degree in a scientific subject
  • Regulatory experience of Class III medical devices
  • Knowledge of different sterilisation methods including Gamma and Ethylene Oxide (ETO)
  • Knowledge of regulatory requirements for medical devices in global markets, particularly MDSAP
    • Essential Skills and Behaviours
  • Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.
  • Able to lead by example and act as a role model.
  • Excellent written communication and presentation skills.
  • Good organisation and leadership skills and attention to detail.
  • A can-do, customer-focused -attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects.
    • Required skills
  • Biology
  • Chemistry
  • Medical Devices
  • Staff Development
  • Technical Files

    • Keyskills :
    Biology Chemistry Medical Devices Staff Development Technical Files

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