Regulatory Affairs Director, APAC
2 weeks ago
At Solventum, we are seeking a highly skilled and experienced Regulatory Affairs Director to lead our APAC Regulatory Affairs team. This role will be responsible for developing and executing regulatory strategies to achieve product approvals faster than competitors.
The Impact You'll Make in this Role- Develop and execute regulatory strategies to achieve product approvals faster than competitors.
- Direct 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.
- 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.
To be successful in this role, you will need to have:
- 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 location: Remote – must reside in an APAC country.
Travel: May include up to 25% domestic/international.
Relocation Assistance: Is not authorized.
Must be legally authorized to work in the 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 is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company 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.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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