Senior Regulatory Affairs Specialist
Core
Develop regulatory plans, review design documentation, and prepare submissions for medical device approvals in the US, Canada, and EU.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions (FDA 510(k), Health Canada), design control documentation, and global regulatory strategies.
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
US Medical Device regulations, Health Canada guidance, EU MDR, product lifecycle management, design controls, risk management, verification and validation, product labeling
Preferred skills
RAPS Regulatory Affairs Certification (RAC), Masters in Regulatory Science
Technologies
FDA 510(k), Health Canada submissions, EU MDR
Responsibilities
Develop regulatory plans and review design input/output documentation; Determine regulatory pathways and formulate strategies for US and Canadian markets; Author and lead regulatory documentation and submissions; Coordinate with technical experts to provide data for regulatory agencies; Provide risk-based guidance to projects; Collaborate with international counterparts for global submissions.
Seniority
Senior, hands-on IC
