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About the Role:
- This contract position supports global regulatory CMC activities for drug-device combination products.
- You will help shape regulatory strategies and ensure submissions meet applicable requirements.
- The role sits at the intersection of regulatory affairs, device development, quality, clinical, and human factors.
Key Responsibilities:
- Review CMC sections of regulatory submissions for development and commercial device programs.
- Contribute to global regulatory CMC strategies for combination products.
- Provide regulatory assessment and guidance on product compliance and change controls.
Requirements:
- Bachelor’s degree in a relevant life-science or technical discipline.
- 4+ years of experience in medical device, pharmaceutical, or related industry.
- Strong knowledge of FDA, EU MDR, ISO standards, and design controls.
Benefits:
- Remote contract opportunity based in the United States.
- Competitive compensation of $75–$80 per hour.
- Exposure to global regulatory frameworks and cross-functional teams.
Unknown
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.