Regulatory Affairs Professional

6 days ago


Singapur, Singapore Boston Scientific Full time

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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