Global regulatory expertise in product submissions
Pre-market submission preparation and maintenance
Globus Medical is seeking a Sr Regulatory Affairs Specialist to coordinate and prepare regulatory submissions for medical devices, ensuring compliance with local and regional requirements. The ideal candidate will have significant experience in the medical device industry and a strong understanding of regulatory processes
Job Summary
The role involves coordinating document packages for regulatory submissions to ensure compliance with local and regional registration requirements.
Candidates must demonstrate global regulatory expertise by evaluating changes against local regulations and collaborating with various departments.
The position requires staying abreast of regulatory procedures and recommending strategies for the earliest possible approvals of clinical trial applications.
Matching Summary
Match Score: 85
Globus Medical is seeking a Sr Regulatory Affairs Specialist to coordinate and prepare regulatory submissions for medical devices, ensuring compliance with local and regional requirements. The ideal candidate will have significant experience in the medical device industry and a strong understanding of regulatory processes.
Skills & Requirements
Must-have
5+ years medical device industry experience
Global regulatory expertise in product submissions
Pre-market submission preparation and maintenance
Nice-to-have
Ability to evaluate regulatory impact of changes
Strong project planning and deadline management skills
Knowledge of AdvaMed and MedTech Codes
Key Requirements
Bachelor's degree plus 5 years experience or Master's plus 3 years
Minimum 5 years related experience in medical device industry
Solid understanding of regulatory terminology and pre-market submission types