Regulatory Affairs Director (Remote - United States)

Solventum; Maplewood (NJ); Remote; USD 212.000 - 291.000; Vollzeit

Zusammenfassung

Solventum, the new company built on 3M Health Care’s legacy, seeks a Regulatory Affairs Director to lead global regulatory strategies for Dental Solutions, a portfolio exceeding $1 billion in revenue. You will partner with R&D, QA and Clinical Affairs to accelerate approvals and ensure sustained market access worldwide.

Remote US role with up to 25% travel. You’ll have a bachelor’s and 10+ years in Regulatory Affairs, global-team leadership, and cross-country regulatory experience.

Qualifikationen

• Bachelor's degree or higher and 10 years of Regulatory Affairs experience in dental/medical device/healthcare.
• Master's degree in Science, Engineering, or related field is a plus.
• Experience leading global teams across countries and regions.
• Experience communicating with stakeholders through verbal discussions, presentations, and written communications.
• Experience supporting regulatory affairs activities across multiple countries and regulatory authorities.
• Experience in complex matrixed organizations and cross-functional collaboration.

Aufgaben

• Develop and execute regulatory strategies to achieve product approvals faster than competitors.
• Direct complex decision making among stakeholders and senior leaders in evolving regulatory areas.
• Advise on regulatory strategy development, authority interactions, and submissions for Dental Solutions portfolios.
• Collaborate with R&D, QA, and Clinical Affairs to integrate regulatory requirements into development and lifecycle management.
• Participate in global leadership meetings representing regulatory affairs and support business objectives.
• Mentor regulatory staff across product modalities and establish team goals aligned with corporate strategy.

Kenntnisse

Global regulatory leadership

Cross-country collaboration

Stakeholder communication

Regulatory submissions

Matrixed organization experience

Ausbildung

Bachelor's degree or higher in regulatory affairs or related field

Master's degree in Science/Engineering or related field

Jobbeschreibung

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we're committed to protecting your personal information-learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/

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 technical discipline (completed and verified prior to 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.

Work location: Remote (United States)

Travel: May include up to 25% domestic and international

Relocation Assistance: Not authorized

Must be legally authorized to work in 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.

Applicable to US Applicants Only: The expected compensation range for this position is $211,600 - $290,950, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.