Senior Regulatory Affairs Director for APAC Region
2 days ago
Solventum, a pioneer in game-changing innovations at the intersection of health, material, and data science, is seeking an experienced Regulatory Affairs Director to lead our APAC team. As a key contributor to governance decisions, you will play a strategic role in shaping our regulatory strategy.
Job Description
The Regulatory Affairs Director will oversee the development and execution of regulatory strategies to achieve product approvals faster than competitors. This includes directing complex decision making among stakeholders and senior leaders in an area of regulatory that is complex and evolving. You will also advise and guide the regulatory strategy development, Health Authority interactions, and submission activities to support our Med-Surg and Dental Solutions product portfolios. Additionally, you will 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.
Requirements
To succeed in this role, you must have a Bachelor's degree or higher in a Science or Engineering discipline, with ten (10) or more years of Regulatory Affairs experience in the medical device industry. A Master's degree in a Science or Engineering discipline is highly desirable. Your expertise should include 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, and detail-oriented with the ability to navigate matrix environments. The ideal candidate should be fluent in English and reside in an APAC country.
Benefits
Solventum offers competitive pay and benefits, benchmarked with other companies comparable in size and scope. As a valued member of our team, you will enjoy a range of programs to support your well-being, both physically and financially. We prioritize maintaining the highest standards of integrity and professionalism in our recruitment process.
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