Regulatory Affairs Professional
6 days ago
About the Role
Boston Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring the timely and successful approval of our medical devices in the market.
Key Responsibilities
- Develop and implement regulatory strategies to ensure compliance with local and international regulations.
- Prepare and submit regulatory applications to local health authorities and agencies.
- Ensure product registrations are reviewed and renewed as required.
- Collaborate with cross-functional teams to ensure regulatory requirements are met.
- Stay up-to-date with local regulatory updates, guidelines, and new regulations.
- Establish relationships with local medical device industry groups and advocate for regulatory issues.
- Support the development of regulatory strategies and plans with regional and global partners.
- Complete mandatory quality training and ensure compliance with internal quality systems.
- Support internal and external audits.
- Review and obtain approval for promotional materials.
Requirements
- Minimum 3-5 years of experience in Medical Device Regulatory Affairs.
- Knowledge of GDPMD and regulatory submissions for ASEAN countries is a plus.
- Strong analytical and critical thinking skills.
- Excellent communication and teamwork skills.
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