Regulatory Affairs Leader - Asia

About the role

Solventum (formerly 3M Health Care) is looking for a Regulatory Affairs Leader for Asia. You will provide strategic regional leadership for regulatory strategies covering new and marketed products, act as a key voice for Asia Regulatory Affairs in governance forums, and lead and develop a high-performing regulatory organization. The role is based in a hybrid setting in an APAC country, preferably Singapore, with up to 25% travel.

Key responsibilities

• Develop and execute regulatory strategies to achieve product approvals faster than competitors.
• Guide complex regulatory decisions among stakeholders and senior leaders.
• Advise on regulatory strategy, Health Authority interactions and submissions for the Medical Surgical and Dental Solutions product portfolios.
• Work with R&D, Quality Assurance and Clinical Affairs so regulatory requirements are built into product development and lifecycle management.
• Represent regulatory affairs in business and functional strategy meetings.
• Mentor regulatory staff and set team goals aligned with business and regional strategy.

Required profile

• Bachelor's degree or higher in a science or engineering discipline, plus a Master's degree in science or engineering.
• 10 or more years of regulatory affairs experience in the medical device industry.
• Previous dental, medical device or healthcare experience.
• Ability to manage, direct and develop a global team across multiple countries.
• Deep regulatory experience across multiple APAC countries.
• Legally authorized to work in the country of employment without sponsorship.

Required skills

• Excellent verbal and written communication in English.
• Detail-oriented, able to navigate a complex matrix environment.