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Senior Regulatory Compliance Officer

2 months ago

Singapur, Singapore Boston Scientific Full time

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Boston Scientific. As a key member of our regulatory team, you will be responsible for ensuring the timely and efficient approval of our medical device products.

Key Responsibilities

  • Provide regulatory expertise to support the development and implementation of our business strategy.
  • Prepare and submit regulatory applications to local health authorities and agencies.
  • Ensure product registrations are reviewed and renewed as required.
  • Stay up-to-date with local regulatory updates, guidelines, and new regulations, and implement changes as necessary.
  • Establish and maintain relationships with local medical device industry groups and regulatory agencies.
  • Liaise with regional and global partners to provide regulatory support and develop strategies.
  • Support internal and external audits, and ensure compliance with our internal quality system and policy.
  • Review and obtain approval for promotional materials, as necessary.

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, with the ability to work independently or as part of a team.

About Boston Scientific

We are a global leader in medical science, committed to solving the challenges that matter most. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient outcomes, create value for our customers, and support our employees and communities.