Senior Regulatory Affairs Specialist (Remote - United States)

SOLVENTUM; Austin (TX); Remote; USD 124,000 - 171,000; Full time

Job summary

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for Restorative Healing Technologies on a global scale. This remote US role emphasizes building regulatory strategy, coordinating cross-functional teams, and ensuring compliance from development through lifecycle management.

You will drive registrations, submissions, and post-market obligations while collaborating with contract organizations and stakeholders across regions.

Qualifications

• Bachelor’s degree (or higher) with 7+ years regulatory affairs experience in a regulated industry.
• Experience with 510(k), EU MDR or other international medical device submissions.
• Experience supporting ISO 13485 and/or MDSAP audits.
• Experience with regulatory activities for devices and software/embedded systems.

Responsibilities

• Develop regulatory strategies to achieve timely product market authorizations.
• Lead cross-functional decision-making on regulatory issues.
• Prepare and submit regulatory documents per local requirements.
• Maintain regulatory systems and data integrity to support operations.
• Support ISO 13485 and MDSAP audits and regulatory inspections.
• Advise on post-market regulatory obligations throughout product lifecycle.

Skills

Regulatory strategy

Cross-functional liaison

Compliance management

Auditing support

Education

Bachelor's degree or higher

High school diploma or GED

Tools

ISO 13485

MDSAP audits

510(k) submissions

EU MDR submissions

Job description

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy: en-us/home/legal/website-privacy-statement/applicant-privacy/

Job Description:Senior Regulatory Affairs Specialist

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 primarily supporting the Restorative Healing Technologies 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 businessYou will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

• 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 areas of regulation that are complex and evolving.
• Participating in global business and functional strategic meetings and forums while representing Regulatory Affairs.
• Performing regulatory assessments and determining registration plans with the business for strategic implementation.
• Articulating global registration requirements and compiling regulatory documents according to local regulatory requirements.
• Submitting registration documents and following 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, support 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 providing necessary regulatory information, updates, and documentation to the organization.
• Supporting ISO 13485, Medical Device Single Audit Program (MDSAP), and Technical Surveillance audits.
• Supporting additional duties and completing other responsibilities or projects as assigned.

Your Skills and Expertise

To set you up for success in this role from day one, 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 within a regulated industry in a private, public, government or military environment ORHigh School Diploma/GED (completed and verified prior to start) AND eleven (11) years of Regulatory Affairs experience within a regulated industry in a private, public, government or military environment
• Additional qualifications that could help you succeed even further in this role include: Master’s Degree or higher in a scientific, engineering, regulatory, or quality discipline, Three (3) years of experience preparing and/or supporting regulatory submissions, including 510(k) submissions, EU MDR submissions, or other international medical device regulatory submissions, Three (3) years of experience supporting ISO 13485 and/or MDSAP audits, Experience supporting regulatory activities for negative pressure wound therapy devices and/or wound care medical devices, Experience supporting regulatory activities for absorbable wound care dressings and matrices, Experience supporting regulatory activities for electro-mechanical devices and/or embedded or stand-alone software medical devices

Work location: Remote (United States)Travel: May include up to 10% domestic/internationalRelocation Assistance: Not authorizedMust 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 $124,000 - $170,500, 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: en-us/home/our-company/careers/#Total-Rewards

Responsibilities and Compliance

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.

Equal Opportunity Employer

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, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.