Regulatory Affairs Director (Remote - United States)
About The Position
The Regulatory Affairs Director provides global leadership for the development and execution of regulatory strategies supporting new and marketed products within Solventum’s Dental Solutions business. The role is a strategic partner to the business, shaping regulatory approaches that enable innovation, accelerate growth, and maintain market access across product portfolios. It uses knowledge of global regulatory pathways to influence product development and business strategies, balance business objectives with patient and customer needs and regulatory requirements, assess regulatory pathways and market opportunities, inform investment and prioritization decisions, and identify and mitigate regulatory risks. For novel and new-to-the-world technologies, the Director develops forward-looking strategies to navigate evolving requirements and establish viable pathways to market. The position advises on regulatory strategy, interactions with regulatory authorities, and submission activities; collaborates with R&D, Quality Assurance, and Clinical Affairs to integrate regulatory requirements into product development and lifecycle management; represents Regulatory Affairs in global business and functional leadership forums; and mentors staff and teams across product modalities. The role is remote in the United States and may include up to 25% domestic and international travel. Relocation assistance is not authorized. Applicants must be legally authorized to work in the country of employment without employment visa sponsorship.
Requirements
- Bachelor’s degree or higher, completed and verified before start.
- Ten years of Regulatory Affairs experience in the dental, medical device, or healthcare industry.
- Must be legally authorized to work in the country of employment without sponsorship for employment visa status.
Nice To Haves
- Master’s degree in Science, Engineering, or a related technical discipline, completed and verified before start.
- Experience leading and developing global teams across multiple countries and regions.
- Experience communicating with stakeholders through verbal discussions, presentations, and written communications.
- Experience supporting Regulatory Affairs activities across multiple countries, regions, and regulatory authorities.
- Experience working within complex matrixed organizations and collaborating across functional teams to achieve business objectives.
Responsibilities
- Develop and execute regulatory strategies to achieve product approvals faster than competitors.
- Direct complex decision-making among stakeholders and senior leaders on complex and evolving regulatory matters.
- Advise and guide regulatory strategy development, regulatory authority interactions, and submission activities for Dental Solutions product portfolios.
- Collaborate with R&D, Quality Assurance, and Clinical Affairs to integrate regulatory requirements into product development and lifecycle management.
- Participate in global business and functional strategic leadership meetings and forums, representing the Regulatory Affairs perspective while supporting the business.
- Mentor and guide regulatory staff and teams working across all product modalities.
- Establish team goals and objectives aligned with business strategies.
- Comply with corporate policies, procedures, and security standards while performing assigned duties.
Benefits
- Medical, dental, and vision benefits
- Health Savings Accounts
- Health Care and Dependent Care Flexible Spending Accounts
- Disability benefits
- Life insurance
- Voluntary benefits
- Paid absences
- Retirement benefits
- May be eligible for variable incentive pay
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What This Job Offers
Job Type
Full-time
Career Level
Director
