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Regulatory Affairs Manager - Medical Devices

Vacancy Title: Regulatory Affairs Manager - Medical Devices
Contract Type: Permanent
Location: Leeds, West Yorkshire
Industry:
Salary: Company Benefits
Start Date: ASAP
REF: J907830_1616675071
Contact Name: Ben George
Contact Email: ben.george@russell-taylor.co.uk
Vacancy Published: 18 days ago

Vacancy 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.

Role:

  • 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.

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k