Regulatory Affairs Leader - Asia

SGP KCI Medical Asia Pte. Ltd.; Singapore; Hybrid; SGD 180,000 - 280,000; Full time

Job summary

Solventum is seeking a Regulatory Affairs Leader for Asia to provide regional leadership for regulatory strategies supporting new and marketed products across the APAC region.

You will lead governance forums, collaborate with R&D, QA, and Clinical Affairs, and mentor a global team to deliver regulatory excellence and sustained market access.

Qualifications

• 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 science or engineering discipline and global team leadership capabilities.

Responsibilities

• Develop and execute regulatory strategies to achieve product approvals faster than competitors.
• Lead Asia Regulatory Affairs governance forums and advise on submissions.
• Advise and guide regulatory strategy development, Health Authority interactions, and submissions.
• Collaborate with R&D, Quality Assurance, and Clinical Affairs to integrate regulatory requirements.
• Participate in leadership meetings representing regulatory affairs across portfolios.
• Mentor regulatory staff and teams across multiple countries.

Skills

Regulatory affairs

English communication

Leadership

Education

Bachelor's degree in Science or Engineering

Master’s degree in science or engineering

Job description

Job Description

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/

3M Health Care is now Solventum. At Solventum, we enable 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. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. 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

As the Regulatory Affairs Leader for Asia, you will provide strategic regional leadership for the development and execution of regulatory strategies supporting both new and marketed products across the region. Serving as a key point of connection for Asia Regulatory Affairs, you will provide leadership and perspective to governance forums, helping shape decisions, align priorities, and advance the strategic direction of the region. You will build trusted, collaborative relationships across business and functional stakeholders, senior leadership, and external partners and contract organizations. You will also lead and develop a high-performing regulatory organization with the capabilities, capacity, and expertise necessary to deliver against business priorities. Through strong leadership and regulatory insight, you will enable innovation, sustainable growth, and continued market access across multiple product portfolios. As the Regulatory Affairs Leader, 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:

• Develop and execute regulatory strategies to achieve product approvals faster than competitors.
• Direct complex decision making among stakeholders and senior leaders in areas of regulatory that are complex and evolving.
• Advise and guide the regulatory strategy development, Health Authority interactions, and submission activities to support the Medical Surgical 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.
• Participate in business and functional strategic leadership meetings and forums representing regulatory affairs perspective while supporting Medical Surgical and Dental Solutions businesses.
• Mentor and guide regulatory staff and teams working across all product modalities.
• Establish goals and objectives for the team aligned with business and regional strategies.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications

• 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 science or engineering discipline
• Previous Dental, Medical Device, or Healthcare experience
• Ability to manage, direct, and develop a global team located in multiple countries
• Excellent verbal and written communication skills in English
• Deep regulatory experience across multiple APAC countries
• Detail oriented with the ability to navigate a complex matrix environment

Work Location & Travel

• Work location: Hybrid - must reside in an APAC country, preferably Singapore
• Travel: May include up to 25% domestic and international
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Solventum Global Terms of Use and Privacy Statement

Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here. Before submitting your application you will be asked to confirm your agreement with the terms.

A new healthcare company with a rich history. With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges. 20,000+ employees worldwide. Solventum relies on the courage and the boundless insights of professionals worldwide to achieve exceptional results for our customers and those who rely on them. Healthcare that leads with heart and humility starts with listening and never finishes, only evolves. As long as healthcare challenges remain unsolved, we will be here, united by empathy and a relentless belief that countless lives are improved through our work. Operations in 38 countries. Driven by our dedication to improved outcomes for all we serve, we break through by making unprecedented connections that impact lives. In more than 300 offices and facilities around the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders. To realize our shared vision, we harness diverse talents and perspectives from every background to not only address our customers' most urgent priorities but anticipate the needs of the future.