APAC Regulatory Affairs Leadership Opportunity

2 weeks ago


SG SINGAPORE VIRTUAL Solventum Full time
About Solventum

Solventum is a pioneering healthcare company that empowers better, smarter, safer healthcare to improve lives. With a legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Our mission is to make an impact by developing and executing regulatory strategies that drive product approvals and foster a culture of innovation.

Job Description

The APAC Regulatory Affairs Director will lead our strategic and impactful team across multiple countries, including China and Japan. This role will serve as a primary point of contact for APAC team members and contribute to governance decisions for strategic alignment and direction. You will build strong relationships across stakeholders, management, and contract organizations, and develop a team with the appropriate capacity and competence to support business plans.

Responsibilities
  • Develop and execute regulatory strategies to achieve product approvals faster than competitors
  • Direct complex decision-making among stakeholders and senior leaders in a rapidly evolving regulatory environment
  • Advise and guide regulatory strategy development, Health Authority interactions, and submission activities for Med-Surg and Dental Solutions product portfolios
  • Collaborate with internal teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure regulatory requirements are integrated into product development and lifecycle management processes
  • Mentor and guide regulatory staff and teams working across all product modalities
  • Establish goals and objectives
Requirements

To excel in this role, you must possess:

  • Bachelor's degree or higher in a Science or Engineering discipline
  • Ten (10) or more years of Regulatory Affairs experience in the medical device industry
  • Master's degree in a Science or Engineering discipline
  • Previous Medical Device / Healthcare experience
  • Ability to manage, direct, and develop a team located in multiple countries, including China and Japan
  • Excellent verbal and written communication skills in English
  • Deep regulatory experience across multiple APAC countries
  • Detail-oriented with the ability to navigate matrix environments
Location and Benefits

This role is remote-based, requiring residency in an APAC country. You may be required to travel up to 25% domestically and internationally. Solventum offers competitive pay and benefits, benchmarked with other companies of similar size and scope. We prioritize maintaining high standards of integrity and professionalism in our recruitment process.



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