Senior Regulatory Affairs Engineer
Core
Enable global market access for medical devices by ensuring regulatory approvals and compliance across targeted markets.
Role type
Senior Regulatory Affairs Engineer (Team Lead)
Builds
Medical device products for hospitals and clinics
Domain
MedTech / Precision radiation medicine
Deliverable
client delivery
Required skills
Regulatory submissions, project management, global regulations knowledge, mentoring colleagues, cross-functional collaboration
Preferred skills
Quality commitment, proactive change driving, creative problem solving
Technologies
None stated
Responsibilities
Ensure and maintain regulatory approvals and compliance across targeted markets; Prepare and submit regulatory documentation to governing authorities; Translate regulations into clear business requirements; Collaborate with cross-functional teams across the product lifecycle; Act as a senior point of contact and support and guide team members in day-to-day activities; Liaise with regulatory authorities and internal stakeholders; Drive continuous improvement and process optimization; Authorize regulatory documents and support audits and reporting