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Staff Regulatory Affairs Specialist
Skills
Class III Medical DevicesCross-Functional Team LeadershipEngineeringInternational MarketingMedical DevicesRegulatory AffairsRegulatory Intelligence
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Bachelor’s degree in engineering science or related field
- Minimum 4 years of experience in an FDA-regulated industry
- Minimum 2 years of experience in regulatory affairs
- Experience supporting regulatory submissions or compliance activities
- Knowledge of U.S. and international medical device regulations
Nice to have
- Cross-functional
- Detail-oriented
- Analytical
- Collaborative
Day to day
- Develop and execute regulatory strategies to maintain market access for post-market products across global regions.
- Evaluate regulatory requirements and determine submission pathways for product changes in line with applicable regulations.
- Author and submit regulatory documents including FDA submissions and international dossiers to support approvals and updates.
- Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.
- Partner with cross-functional teams to support agency interactions and maintain compliance through updated procedures.