What will you be doing?- 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
What will you need to be successful?- 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
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. You will be entitled to receive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.
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