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Solventum · 2 days ago

Senior Regulatory Affairs Specialist (Remote - United States)

United States

Full-time

Remote

Senior Level

$132K/yr - $170K/yr

7+ years exp

Solventum is a new healthcare company focused on creating breakthrough solutions to improve lives and support healthcare professionals. The Senior Regulatory Affairs Specialist will manage regulatory compliance for a portfolio of medical devices, ensuring successful product approvals and ongoing compliance throughout the product lifecycle.

Medical Device

No H1B

Responsibilities

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 determining registration plans with 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 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 providing necessary regulatory information, updates, and documentation to the organization

Supporting ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits

Supporting any other duties within the role or tasks assigned from time to time

Qualification

Regulatory AffairsMedical Device ExperienceRegulatory SubmissionsElectromechanical DevicesISO 13485 ComplianceSoft Skills

Required

Bachelor's Degree or higher (completed and verified prior to start) AND seven (7) years of experience in Regulatory Affairs & Medical Device experience in a private, public, government or military environment

High School Diploma/GED (completed and verified prior to start) and eleven (11) years of experience in Regulatory Affairs & Medical Device in a private, public, government or military environment

Three (3) years of experience with electromechanical medical devices

Three (3) years of experience with regulatory submissions which include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions

Preferred

Bachelor's Degree or higher in electrical engineering, mechanical engineering or software engineering/programming

Advanced degree in Scientific, Engineering or Regulatory/Quality

Five (5) years of experience with electromechanical medical devices

Five (5) years of experience with regulatory submissions which may include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions

Experience with temperature management, negative pressure wound devices, and/or wound care devices

Experience with stand-alone software devices and cybersecurity

Three (3) years of experience with supporting 13485 and MDSAP audits