[Hiring] Senior Regulatory Affairs Specialist @SOLVENTUM

Role Description

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 ongoing 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.

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 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.

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
• OR 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

• 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

Requirements

• Work location: Remote (United States)
• Travel: May include up to 10% domestic/international
• Relocation Assistance: Not authorized
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Benefits

• Competitive pay and benefits
• Medical, Dental & Vision
• Health Savings Accounts
• Health Care & Dependent Care Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• Paid Absences
• Retirement Benefits