Job Summary:
We are looking for a highly experienced Senior / Manager – Regulatory Affairs with expertise in 510(k) submissions for medical devices used in biologics. The candidate will be responsible for driving regulatory strategies, ensuring compliance, and managing submissions for products associated with biologics, cell-based therapies, and related medical devices.
Key Responsibilities:
- Lead end-to-end 510(k) submissions for medical devices associated with biologics.
- Prepare and review regulatory dossiers in compliance with US FDA and global regulatory requirements.
- Develop regulatory strategies for biologics-linked medical devices and combination products.
- Ensure compliance with FDA regulations, ISO standards, and biologics guidelines.
- Coordinate with cross-functional teams including R&D;, Quality, Clinical, and Manufacturing.
- Manage product registrations, renewals, supplements, and lifecycle changes.
- Act as a primary liaison with regulatory authorities during submissions and audits.
- Track regulatory updates in biologics and medical device domains and implement changes.
Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or related field.
Experience:
- 6–10 years of experience in Regulatory Affairs.
- Strong experience in medical devices and biologics/combination products.
- Hands-on experience in 510(k) submissions is mandatory.
Skills Required:
- Strong knowledge of US FDA regulations for medical devices and biologics.
- Experience with combination products and regulatory pathways.
- Excellent leadership, project management, and stakeholder handling skills.
- Solid documentation and analytical abilities.
- Effective communication and regulatory strategy planning skills.