Regulatory Affairs Specialist
1 month ago
Job Summary
Boston Scientific is seeking a highly skilled Senior / Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring rapid and timely approvals for our product line by planning and managing all product registrations, as well as interacting with regulatory agencies to expedite approval of pending registrations.
Key Responsibilities
- Provide input on regulatory-related issues associated with compliance and achieving business objectives.
- Prepare, coordinate, and submit regulatory applications to local health authorities and agencies.
- Ensure product registrations are reviewed and renewed as required.
- Work with stakeholders to minimize business disruption and ensure timely approval of product changes and amendments.
- Stay up-to-date with local regulatory updates, guidelines, and new regulations, and implement them accordingly.
- Establish relationships with local medical device industry groups and advocate for regulatory issues and influence local policies.
- Liaise with regional and global partners on regulatory affairs and provide support in developing regulatory strategies and plans.
- Complete mandatory quality training and ensure compliance with internal quality systems and policies.
- Support internal and external audits.
- Review and obtain approval for promotional materials.
Key Skills and Experiences
- 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, as well as solid oral and written communication skills in English and Indonesian.
- Team player with a strong ability to work independently.
Boston Scientific is a leader in medical science with over 40 years of experience. We are committed to advancing science for life and improving patient lives through innovative medical solutions. If you are a natural problem-solver with a passion for making a meaningful difference, we encourage you to apply and look forward to connecting with you.
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