Principal Regulatory Affairs Specialist (Remote - United States)

Principal Regulatory Affairs Specialist

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.

The Impact You'll Make in this Role

As a Principal Regulatory Affairs Specialist, 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:

• Serving as the regulatory affairs lead on cross-functional teams, with ownership of product-line regulatory submissions and registrations for the Dental Solutions business across global markets
• Driving regulatory strategy and execution for Tier 1, high-volume markets, including the United States, Canada, and the European Union, while partnering with international regulatory affairs teams to ensure products are registered globally in alignment with business strategy
• Conducting global regulatory change assessments and coordinating associated activities for assigned drug and medical device products
• Leading or supporting regulatory filings for continuity and lifecycle projects, directly for the United States and European Union and in partnership with global teams for rest-of-world markets
• Providing regulatory review and input on technical documentation and reports, including support for labeling and registration updates related to the company spin-off
• Contributing to the development, implementation, and continuous improvement of regulatory processes, including documentation and management of relevant metrics
• Supporting risk management, vigilance reporting, and other quality-related initiatives with minimal oversight
• Communicating regulatory outcomes and technical information to cross-functional teams, business partners, and regional stakeholders through reports, standards, and presentations
• Supporting the implementation of key corporate initiatives and enabling tools, including use of emerging digital and AI-enabled solutions within the regulatory environment

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 seven (7) years in regulatory affairs experience in the drug and/or medical device industry

In addition to the above requirements, the following are also required:

• Experience authoring regulatory submissions and technical documentation for drug and medical device products in the United States, Canada, and the European Union, with experience supporting regulatory activities in EMEA, APAC, and LATAM
• Experience authoring regulatory strategies and regulatory change assessments
• Experience revising, reviewing, and approving product labeling, including marketing claims, to ensure compliance with global regulatory requirements.
• Experience with NDA and OTC monograph drugs and medical devices

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

• Bachelor's Degree or higher (completed and verified prior to start) in Biology, Chemistry, Biomedical Engineering
• Experience with dental products
• Experience supporting design control verification and validation activities, including clinical requirements for medical devices, such as documenting and performing to applicable requirements and supporting the writing, review, and approval of protocols and reports
• Experience supporting or contributing to clinical strategy activities for medical device products
• Experience working with formulated products
• Experience working with fluoride-containing drug and medical device products
• Experience working with borderline products, such as drugs, cosmetics, and/or natural health products
• Experience applying regulatory knowledge through cross-functional project management, including stakeholder engagement, international submission support, and resolving regulatory issues across medical device product teams
• Experience applying regulatory principles and professional practices to address complex regulatory issues, including development of clear regulatory documentation and written communications
• Experience applying structured process-improvement approaches within regulatory or quality-related workflows, including participation in training or professional development activities
• Experience working across multiple product portfolios, technologies, or business areas, including use of regulatory information resources, systems, and data sources to build regulatory understanding and support decision-making

Work location: Remote in the United States

Travel: May include up to 10% 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 $142,800 - $196,350, 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:

Responsibilities 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.

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