Principal Regulatory Affairs Specialist (Remote - United States)

Principal Regulatory Affairs Specialist (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

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:

• Leading preparation and submission of 510(k) applications and other regulatory filings for Software as a Medical Device (SaMD)
• Developing and executing global regulatory strategies for product registrations in the US, EU (MDR), and Canada
• Supporting international regulatory teams with product registrations across the Custom Smiles Portfolio
• Ensuring compliance with global regulations and reviewing technical and software documentation for submissions
• Collaborating cross-functionally to integrate regulatory requirements into product development

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 of regulatory affairs experience in medical devices
• OR
• High School Diploma/GED and eleven (11) years of regulatory affairs experience in medical devices
• AND
• In addition to the above requirements, the following are also required:
• Five (5) years of experience with Software as a Medical Device (SaMD)
• Experience authoring 510(k) submissions for SaMD
• Experience supporting regulatory submissions in the United States and European Union
• Additional qualifications that could help you succeed even further in this role include:
• Master's degree in Regulatory Affairs
• Experience supporting regulatory submissions in Canada
• Regulatory Affairs Certification (RAC)
• Experience working with dental or orthodontic medical devices
• Experience applying IEC 62304 standards and Software as a Medical Device (SaMD) lifecycle requirements
• Experience preparing and reviewing regulatory documentation and submissions
• Experience communicating regulatory requirements, risks, and outcomes through written reports, presentations, or cross-functional discussions
• Experience collaborating with cross-functional teams (e.g., R&D, Quality, Clinical, and Commercial) to support regulatory activities

Work location:

• Remote

Travel: May include up to 5% domestic travel

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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