Science & Technology

Regulatory Affairs Specialist

Not Specified

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.

Responsibilities:

  • 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
  • Working knowledge of medical devices regulatory documentation
  • 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
  • Advising scientists and manufacturers on regulatory requirements
  • Resolving complex issues as they arise
  • 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
  • Submitting license applications to authorities to strict deadlines

Qualifications and experience

  • Successful graduation in a Life Science degree or equivalent
  • Proven expertise of medical device Regulatory Affairs on a European Basis
  • 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

Additional information about the process

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Service

Employment Type Contract

Advertiser Type Agency