Regulatory Affairs Director, APAC

1 month ago

SG SINGAPORE VIRTUAL Solventum Full time
Job Description

Solventum is a pioneering company that enables better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You'll Make in this Role
  • You will lead the APAC Regulatory Affairs team, a functional area that is strategic and has corporate-wide impact.
  • This role will serve as a primary point of contact for the APAC team members and as a key contributor to governance decisions for strategic alignment and direction for the area.
  • You will actively build strong relationships across stakeholders, management, and with contract organizations.

As the Regulatory Affairs Director, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

  • Developing and executing regulatory strategies to achieve product approvals faster than competitors.
  • Directing complex decision making among stakeholders and senior leaders in an area of regulatory that is complex and evolving.
  • Advising and guiding the regulatory strategy development, Health Authority interactions, and submission activities to support the Med-Surg and Dental Solutions product portfolios.
  • Collaborating with internal teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure regulatory requirements are integrated into product development and lifecycle management processes.
  • Participating 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.
Your Skills and Expertise
  • 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.

In addition to the above requirements, the following are also required:

  • 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 environment.
Work Arrangements
  • Remote work location: must reside in an APAC country.
  • Up to 25% domestic/international travel may be required.

Please note that applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. All email communications from Solventum regarding job opportunities will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

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