Globus Medical is seeking a Manager of Regulatory Affairs to oversee the preparation and submission of regulatory documentation for medical devices to the FDA. The ideal candidate will have significant experience in the medical device industry, specifically in regulatory roles, and should embody the company's values of innovation, customer focus, teamwork, and drive
Job Summary
The role involves preparing, filing, and gaining approval for 510(k), IDE, and PMA submissions to the U.S. Food and Drug Administration.
This position requires guiding the US Regulatory team to achieve timely regulatory clearance while ensuring conformance to 21 CFR regulations.
Candidates must demonstrate dependability, flexibility, and maturity while building effective working relationships with the FDA and internal stakeholders.
Matching Summary
Match Score: 85
Globus Medical is seeking a Manager of Regulatory Affairs to oversee the preparation and submission of regulatory documentation for medical devices to the FDA. The ideal candidate will have significant experience in the medical device industry, specifically in regulatory roles, and should embody the company's values of innovation, customer focus, teamwork, and drive.
Skills & Requirements
Must-have
FDA 21 CFR regulatory compliance
510(k) clearance submission experience
IDE and PMA approval process expertise
Orthopedic or spinal device knowledge
Project management for regulatory filings
Nice-to-have
Panel-track PMA experience preferred
Strong verbal and written communication skills
Ability to travel up to 10% of time
Positive and even-tempered demeanor
Experience with international regulatory submissions
Key Requirements
BS degree in engineering or science-related field
Minimum 8 years experience in medical device industry