Senior Regulatory Affairs Specialist (Remote - USA)

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 (Remote - USA)

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

As a Senior Regulatory Affairs Specialist, you will lead a regulatory affairs team supporting the Negative Pressure Wound Technology portfolio – a functional area that is a strategic growth driver for Solventum and has corporate-wide impact. This role will support teams in early and late-stage product development to advance the product through critical milestones and regulatory activities that lead to product approvals, globally. In addition, this role will support on-going product compliance throughout the device’s lifecycle. You will actively build strong relationships across stakeholders, management, and with contract organizations. You will be responsible for developing a team that has the appropriate capacity and competence to support the strategic plans of the business

As a 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:

• Developing and executing regulatory strategies to achieve new product market authorizations faster than competitors and with differentiated indications and claims.

• Managing complex decision making among cross functional stakeholders in an area of regulatory that is complex and evolving.

• Participating in global business and functional strategic meetings and forums representing regulatory affairs.

• Performing regulatory assessments and determine registration plans with business for strategic implementation.

• Articulating global registration requirements and compile regulatory documents according to local regulatory requirements.

• Submitting registration documents and follow through on all in-process evaluations until regulatory authorization is obtained.

• Acting as the focal point for commercial support pertaining to all regulatory activities.

• Managing regulatory systems and tools to drive operational excellence for effective data tracking and ensure regulatory data integrity.

• Reviewing advertising and promotional materials to ensure claims are aligned with cleared claims.

• Keeping abreast of new regulations and provide necessary regulatory information, updates, and documentation to organization.

• Supporting ISO 13485, Medical Device Singla Audit Program and Technical Surveillance audits.

• Supporting any other duties within the role or task assigned from time to time.

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) from an accredited university AND five (5) years of experience in Regulatory Affairs and/or Medical Device experience in a private, public, government or military environment

OR

• High School D