Nr ref.: /JOBS.pl
Salary: 45000.00-50000.00 British Pound . GBP (Annual)
A client of mine is seeking a regulatory affairs officer with medical device experience to join them on a contract basis.
Job Title: Senior Regulatory Affairs Officer
Be the primary RA representative for the Immunodiagostics products
Develop and deploy global regulatory strategies and manage the pre-market submission of the Immunodiagostics products as well as assist with the registration of products as necessary
Act as the lead RA within a cross-functional project team, providing inputs into New Product Development, changes to existing products and other activities involving the complete life cycle management of products
Be responsible for the planning and implementation of new and updated regulations as applicable to products while working in coordination with global regulatory affairs
Assist Line Manager in gathering relevant KPI and metrics
Lead change projects and site quality review meetings
Bachelors or Masters degree in Science preferably in the Biological Sciences or Regulatory Affairs
Proven experience in regulatory affairs in IVD or medical devices companies. Regulatory Affairs Certified individual preferred.
Ability to make balance decisions in relation to business/customer requirements and offer appropriate advice
Ability to work with minimal supervision with sound technical judgment and analytical skills in a highly matrixed business environment
Ability to coordinate and manage the completion of multiple projects simultaneously
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel within UK and internationally as required
Non-Negotiable Hiring Criteria:
Proven experience in RA in IVD or medical devices companies
Experienced in 510(k) submission or Technical File compilation
Demonstrated experience in navigating complex pre-market submissions.
Experience working in a broader enterprise/cross-division business unit model preferred
Location: South East England
Job Type: Permanent
If you are interested in this role or know anyone who might be please respond with an up to date CV and I will be in touch ASAP.
Ogłoszenie pochodzi z serwisu Jobs.pl.
Proszę czekać - ładowanie treści...