Regulatory Affairs Director, APAC

3 weeks ago


SG SINGAPORE VIRTUAL Solventum Full time
Role Overview:
As the Regulatory Affairs Director for Solventum, you will lead the APAC Regulatory Affairs team, playing a critical strategic role in ensuring compliance and driving business success. Your expertise will be essential in developing and executing regulatory strategies to achieve product approvals faster than competitors.

Key Responsibilities:
  • Develop and execute regulatory strategies to achieve product approvals.
  • Direct complex decision making among stakeholders and senior leaders in the area of regulatory affairs.
  • Advising and guiding the regulatory strategy development, Health Authority interactions, and submission activities to support the 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.
  • Participate in global business and functional strategic leadership meetings and forums representing regulatory affairs perspective while supporting the Med-Surg and Dental Solutions business.
  • Mentoring and guiding regulatory staff and teams working across all product modalities.
  • Establishing goals and objectives.

Requirements:
  • 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.

Work Environment: Remote – must reside in an APAC country. May include up to 25% domestic/international travel. Relocation Assistance: Not authorized. Must be legally authorized to work in the country of employment without sponsorship for employment visa status.

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