Regulatory Affairs Director - APAC
September 16
Description
• As the Regulatory Affairs Director, you will lead the APAC Regulatory Affairs team. • This role will serve as a primary point of contact for the APAC team members. • You will actively build strong relationships across stakeholders, management, and with contract organizations. • You will be responsible for developing a team that has the appropriate capacity and competence to support the strategic plans of the business. • Develop and execute regulatory strategies to achieve product approvals faster than competitors. • Direct complex decision making among stakeholders and senior leaders. • Advise and guide the regulatory strategy development, Health Authority interactions, and submission activities. • Collaborate with internal teams 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.
Requirements
• 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 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.
Benefits
• 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.
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