
Senior Regulatory Specialist MedTech Role
4 days ago
We are seeking a Senior Regulatory Affairs Specialist in Medical Technology to develop and implement regulatory strategies, providing guidance on regulatory matters throughout the product lifecycle of medical devices.
About the Role:- This role requires collaboration with license partners as the Regulatory Affairs Expert, ensuring compliance with healthcare regulations set by relevant agencies.
Main Responsibilities:
- Serve as the primary point of contact for regulatory activities, including regular meetings with license partners.
- Develop, submit, and maintain product registrations for new and existing products during development and licensing activities.
- Conduct regulatory reviews and approvals of product labeling and marketing materials for new products and licensing activities.
Key Requirements:
- Proven experience in regulatory affairs, particularly in the medical technology industry.
- Excellent communication and project management skills.
- Able to work independently and collaboratively within a team environment.
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