Senior Regulatory Affairs Specialist

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Senior Regulatory Affairs Specialist (Solventum)

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.

The Impact You’ll Make in this Role
In this Senior Regulatory Affairs position, you will have the opportunity to act as the lead Regulatory Affairs associate on enterprise-wide strategic cross functional teams for continuity projects related to the 3M & Solventum spin-off for the Dental Solutions business. The role will have a significant impact on the global strategy to make Solventum a stand-alone world class healthcare company.

As a(n) Senior 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:

• Conducting global regulatory change assessments and coordinating associated activities for assigned products.
• Providing global regulatory strategies for changes related to spin-off continuity projects and ensuring these strategies are integrated with the overall RA spin-off plans.
• Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality in addition to excellent organizational, prioritization, oral and written communication skills
• Providing regulatory review of technical reports and documents.
• Providing contributions for development and implementation of regulatory processes.
• Documenting and managing metrics.
• Leading regulatory filings as needed for continuity projects (directly for EU/USA, Canada and supporting ROW).   
• Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight.
• Communicating results of technical tasks to teams supported, respective business group(s) and/or country/region served via reports, standards and/or presentations.
• Leading the implementation of key corporate initiatives and appropriate tools.

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 AND seven (7) years of regulatory affairs in the medical device industry in a private, public, government or military environment

OR

• High School Diploma/GED from AND fourteen (14) years of regulatory affairs in the medical device industry in a private, public, government or military environment

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

• Direct experience authoring submissions/technical documentation
• Direct experience authoring regulatory strategies and regulatory change assessments

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

• Experience working in the dental device field or with dental products
• Experience working with formulated products
• Experience developing regulatory strategies, label and claims review and project management
• Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devi