RA Consultant

Job Description

Define regulatory strategies and pathways.
Establish TF s for all classes I-II
Prepare FDA submissions
Submit global registrations worldwide: coordination and preparation of document packages for regulatory submissions.
Support design and development of products from a regulatory perspective.
Advise on standards, labelling and UDI requirements.
Participates in internal and external audits i.e. FDA inspections, notified body audits according to ISO13485, EUMDR, MDSAP.

Requirement

  • 3+ years’ related experience in the medical device industry.

  • Experience in certified QMS environment per ISO13485 / FDA-QSR.

  • Bachelor's degree or higher in life science-related discipline, engineering, or law

  • Excellent English proficiency

Apply Now