Job Description:
Principal Regulatory Affairs Specialist (Solventum)
3M Health Care is now Solventum
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:
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: 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 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.
