Senior Regulatory Affairs Specialist (Remote - United States)

SOLVENTUM; Clifton (TX); Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental & Vision

Health Savings Accounts

Disability Benefits

Life Insurance

Retirement Benefits

Job summary

Solventum is hiring a Senior Regulatory Affairs Specialist to lead regulatory strategy for the Restorative Healing Technologies portfolio. You will drive global registrations, prepare submissions, and ensure lifecycle compliance for medical devices.

You will collaborate with stakeholders and contract organizations, oversee regulatory data, and guide teams through audits and compliance programs. This role is Remote (United States) with ~10% travel.

Qualifications

• Bachelor's Degree or higher completed and verified prior to start with regulatory experience.
• Seven (7) years of Regulatory Affairs experience in a regulated industry.
• High School Diploma/GED with eleven (11) years of Regulatory Affairs experience.
• Three (3) years of experience preparing and/or supporting regulatory submissions (510(k), EU MDR).
• Experience supporting regulatory activities for wound care and electro-mechanical devices.

Responsibilities

• Develop and execute regulatory strategies to achieve new product authorizations globally.
• Participate in global meetings representing Regulatory Affairs.
• Determine registration plans and compile regulatory documents.
• Submit registration documents and track evaluations to approval.
• Maintain regulatory systems, data integrity, and compliance.

Skills

Regulatory strategy

Global registration

Regulatory submissions

ISO 13485

Regulatory compliance

Education

Bachelor’s Degree or higher

High School Diploma/GED

Master’s Degree

Tools

Regulatory systems and tools

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: 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.

Senior Regulatory Affairs Specialist

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 business.

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

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.

High 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.
• 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.

Remote (United States)

Travel: May include up to 10% domestic/international.

Relocation Assistance: Not authorized H1B status).

Solventum offers many programs to help you live your best life – both physically and financially. 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: of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

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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