Regulatory Affairs Director; Remote

Position: Regulatory Affairs Director (Remote - United States)

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Job Description:

Regulatory Affairs Director 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best.

Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

As the Regulatory Affairs Director, you will provide global leadership for the development and execution of regulatory strategies supporting new and marketed products within Dental Solutions, a growing business exceeding $1 billion in annual revenue. You will serve as a strategic partner to the business, shaping regulatory approaches that enable innovation, accelerate growth, and ensure continued market access across the portfolio.

Leveraging deep knowledge of global regulatory pathways, you will influence product development and business strategies multiple product portfolios, establishing regulatory direction that balances business objectives, patient and customer needs, and regulatory requirements. You will assess regulatory pathways and market opportunities to inform investment and prioritization decisions, proactively identify regulatory risks, and develop effective mitigation strategies. For novel and "new-to-the-world" technologies, you will create forward-looking regulatory strategies that navigate evolving requirements and establish viable pathways to market.

As the Regulatory Affairs Director, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Developing and executing regulatory strategies to achieve product approvals faster than competitors.
• Directing complex decision making among stakeholders and senior leaders in areas of regulatory that are complex and evolving.
• Advising and guiding the regulatory strategy development, regulatory authority interactions, and submission activities to support the Dental Solutions product portfolios.
• Collaborating with internal teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure regulatory requirements are integrated into product development and lifecycle management.
• Participating in global business and functional strategic leadership meetings and forums representing regulatory affairs perspective while supporting the business.
• Mentoring and guiding regulatory staff and teams working across all product modalities.
• Establishing goals and objectives for the team aligned with business strategies.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor's degree or higher (completed and verified prior to start) AND ten (10) years of Regulatory Affairs experience in the dental, medical device, or healthcare industry.

Additional qualifications that could help you succeed even further in this role include:

• Master's degree in Science, Engineering, or a related…