Senior Regulatory Affairs Specialist
About the role
Join our growing Sports Medicine franchise and play a key role in supporting life-changing medical technologies used by patients around the world. This is an opportunity to work collaboratively with global teams while shaping regulatory strategy across the full product lifecycle.
Responsibilities
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
Requirements
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
Qualifications
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
Skills
Global regulatory strategy development
Regulatory submission management
Collaborative team management
Product development and compliance guidance
Regulatory audit support
Regulatory intelligence activities
Training and mentoring
Benefits
Compensation range: $101,500.00 - $152,250.00 USD annually
401k matching program
Discounted stock options
Tuition reimbursement
Medical, dental, and vision coverage
Flexible personal/vacation time off
Paid holidays
Flex holidays
Paid community service day
Wellness offerings
Pay
The anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate’s qualifications, job-related knowledge/skills, geographical location.
Schedule
N/A
Skills
Global regulatory strategy development
Regulatory submission management
Collaborative team management
Product development and compliance guidance
Regulatory audit support
Regulatory intelligence activities
Training and mentoring
Benefits
Compensation range: $101,500.00 - $152,250.00 USD annually
401k matching program
Discounted stock options
Tuition reimbursement
Medical, dental, and vision coverage
Flexible personal/vacation time off
Paid holidays
Flex holidays
Paid community service day
Wellness offerings