Global Regulatory Affairs Officer

Location: Burton upon Trent  |  Staffordshire  |  England
Sector: Life Sciences
Consultant: Matthew Pitcher
Job Reference: CH/HQGlobalRAO
Salary: £30000 - £50000
Job Status: Permanent / Full Time

Very proud to be working on this role for a fantastic company, the role has come about due to continued growth in the company as well as growing global regulatory demand.

This is an exciting opportunity to join a world leading Software Company in the development of IVD medical devices. I am looking for a Corporate Regulatory Affairs Officer at their UK office.

The ideal candidate will have strong regulatory background working with medical devices of different classes. Strong IT background, excellent communication skills along with experience of dealing with competent authorities (e.g. MHRA and others) are mandatory.

Salary bracket £30K – £50K Dependant on experience

Relocation package could be available

if you are interested please send me your CV

Requirement Specification

  • 3+ years minimum Regulatory Affairs experience within medical device environment.

  • Must have ISO 13485 Experience

  • Excellent oral, written, and interpersonal communication skills. A second language (e. g. German, French or Spanish) is preferred.

  • Analytical and problem-solving skills

  • Exceptional organizational and time management skills

  • Ability to work independently and proactively to meet goals and deadlines

  • Experience with 510K premarket submissions is desirable

  • Ability for cross border collaboration in a Corporate Team accompanied by limited business travel

  • Ability for cooperation and  frequent communication with local management and Head of Corporate QM & RA