Regulatory Affairs Director (Remote - United States)

Solventum-; California; Remote; USD 212,000 - 291,000; Full time

Job summary

Solventum seeks a Regulatory Affairs Director to lead global regulatory strategies for Dental Solutions products, guiding regulatory authority interactions and lifecycle management. You will collaborate with R&D, Quality Assurance, and Clinical Affairs to accelerate approvals and maintain market access.

The ideal candidate has a Bachelor's degree and 10+ years in regulatory affairs in dental or medical devices, with proven international leadership. Remote work from the United States is available.

Qualifications

• Bachelor's degree in Regulatory Affairs or related field with 10+ years of regulatory experience in dental/medical devices/healthcare.
• Master's degree in Science/Engineering or related technical discipline is a plus.
• Experience leading global teams across multiple countries and regions.
• Experience communicating with stakeholders through presentations and written communications.

Responsibilities

• Developing and executing regulatory strategies to achieve product approvals faster than competitors.
• Directing complex decision making among stakeholders and senior leaders in regulatory areas that are evolving.
• Advising and guiding regulatory strategy development, regulatory authority interactions, and submission activities.
• Collaborating with R&D, Quality Assurance, and Clinical Affairs to integrate regulatory requirements into product development and lifecycle management.
• Participating in global business meetings representing regulatory affairs perspectives and supporting the business.
• Mentoring and guiding regulatory staff and teams across product modalities.
• Establishing goals and objectives for the regulatory team aligned with business strategies.

Skills

Regulatory Affairs

Regulatory leadership

Global team leadership

Stakeholder communication

Education

Bachelor's degree

Master's degree preferred

Job description

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 Director3M Health Care is now SolventumAt 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 ExpertiseTo 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 internationalRelocation Assistance: Not authorizedMust be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).Supporting Your Well-beingSolventum 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-RewardsResponsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com . Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.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.Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.Solventum Global Terms of Use and Privacy StatementCarefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.Please access the linked document by clicking here . Before submitting your application you will be asked to confirm your agreement with theterms.