Johnson & Johnson Careers

Reg Affairs CE Rep manager

Maidenhead, United Kingdom
Regulatory Affairs

Job Description

Requisition ID: 1805633977W

Regulatory Affairs Manager (m/f) – Medical Devices
Location : Wokingham, Maidenhead, London (UK) or Germany
Closing Date : 15th March 2018

Job description:


Drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation for notifications in the Medical Device area.

  • Ensuring that the company's products comply with relevant legislation and standards
  • Keeping abreast of international legislation, guidelines and customer practices
  • Keeping up to date with a company's product range
  • Developing and writing clear strategies and arguments and explanations for new product licenses, modifications and license renewals
  • Preparing submissions of license variations and renewals
  • Setting and communicating timelines for license variations and renewal approvals
  • Writing clear, accessible product labels and patient information leaflets
  • Planning and developing product trials, Interpreting trial data
  • Advising scientists and manufacturers on regulatory requirements
  • Resolving complex issues as they arise
  • Project managing teams of colleagues involved with the development of new products
  • Maintaining quality systems undertaking and managing regulatory inspections
  • Reviewing company practices and providing advice on changes to systems Liaising with, and making presentations to regulatory authorities and Notified Bodies
  • Submitting license and clinical trials applications to authorities to strict deadlines
  • Negotiating with regulatory authorities and Notified Bodies for marketing authorization
  • Specifying storage labelling and packaging requirements. Liaising closely with the regulatory authorities on a regular basis 


Successful graduation in a Life Science degree or equivalent

  • Proven expertise of medical device Regulatory Affairs on an international basis
  • Business development skill sets with exposure to or having worked in a regulatory consultancy model
  • Be able to demonstrate driving partnerships within the industry
  • Experience within a clinical trial program environment
  • Proven ability of interpreting legislation and impact to meet commercial needs
  • Proven capability of successful working relationships with regulatory bodies
  • Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions
  • Excellent communication and interpersonal skills, ability to influence and motivate
  • Proven success at managing and driving a team to meet strategic goals and KPIs

Primary Location
United Kingdom-England-Maidenhead
J&J Consumer Services EMAE., Ltd (8675)
Job Function
Regulatory Affairs
Requisition ID