Regulatory Affairs Manager - Medical Devices

Job Title: Regulatory Affairs Manager - Medical Devices
Contract Type: Permanent
Location: Leeds, West Yorkshire
Salary: Company Benefits
Start Date: ASAP
Reference: J907830_1616675071
Contact Name: Ben George
Contact Email:
Job Published: March 25, 2021 12:24

Job Description

Role: Regulatory Manager - Medical Devices

Salary: Competitive + Benefits

Location: Leeds

Russell Taylor Group has a fantastic opportunity to join our clients Medical Device Company as Regulatory Manager. You will have Medical Device experience and worked with Class IIB or Class III Medical Devices.


  • Act as back-up/deputy PRCC in lieu of Compliance Director.
  • Generate Technical Files for new products.
  • Update technical files as a results of changes to products or regulations, such as MDR,
  • and ensure that CE marking is maintained.
  • Conduct distributor approval.
  • Conduct registration in new markets including MDSAP.
  • Undertake Regulatory submissions including 510(k) for the United States.
  • Prepare for and attend regulatory audits.
  • Support the complaints function of the Quality team with regard to regulatory reporting and vigilance.
  • Provide line management support, direction and coaching to regulatory team and conduct regular catch ups and annual Staff Development Reviews.
  • 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.

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