Managing the post market RA team which handles the following activities:
Support design and post market compliance of products from a regulatory perspective
Handling Vigilance, MDR and authorities inquiries of complaints
Support the investigation process from a regulatory perspective
Responsible for managing product field action
Responsible on regulatory assessment related QMS process
Responsible of companys PSUR
Direct manager: VP of R&A
Requirements: o BSc in a scientific area, (Bio-medical or Quality Engineering - an advantage) or acknowledged regulatory course graduate
Job skills:
o 2-4 years medical device/pharmaceutical post market experience
o Knowledge and experience with the following regulatory systems: EU / Canada /US - advantage to other regulation
o Minimum 2 years management experience
o Strong verbal and written communication skills
o Good technology expertise is essential
o Experience in front of the authorized authorities
o Understanding of risk management disciplines
This position is open to all candidates.