Developing and executing global regulatory strategies for new and modified medical devices
Preparing and managing regulatory submissions to obtain and maintain global market approvals
Providing regulatory guidance to cross functional teams across product development, manufacturing, and compliance activities
Assessing product and manufacturing changes to ensure continued regulatory compliance throughout the product lifecycle
Acting as a company representative with global regulatory agencies, building and maintaining strong professional relationships
Supporting regulatory audits, advocacy initiatives, and regulatory intelligence activities
Developing and maintaining regulatory SOPs and providing training and mentoring to colleagues

Bachelor’s degree or equivalent experience, preferably in a scientific or technical discipline
5 or more years of Regulatory Affairs or related experience within the medical device industry
Proven experience managing FDA 510(k) submissions and EU MDR filings
Strong understanding of global regulatory requirements and medical device development processes
Excellent written and verbal communication skills, including technical writing
RAPS certification is an advantage

Senior Regulatory Affairs Specialist

Key skills