Regulatory Affairs Specialist

3 days ago


Singapur, Singapore Boston Scientific Full time

Job Summary

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

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.
  • Collaborate with cross-functional teams to minimize business disruption and ensure compliance with regulatory requirements.
  • Stay up-to-date with local regulatory updates, guidelines, and new regulations, and implement changes as necessary.
  • Establish relationships with local medical device industry groups and advocate for regulatory issues and policy changes.
  • Support regional and global partners in regulatory affairs and provide input on 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.

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, with excellent oral and written communication skills in English and Indonesian.
  • Team player with a strong commitment to quality and regulatory compliance.

About Boston Scientific

As a leader in medical science for over 40 years, we are 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 lives, create value for our customers, and support our employees and communities. We are a global business and corporate citizen, dedicated to applying our values to everything we do.



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