Senior Regulatory Affairs Specialist (Remote - United States)

SOLVENTUM

1d • Remote

About The Position

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 have responsibility for managing the regulatory compliance for a broad portfolio of medical devices within the Infection Prevention and Surgical Solutions and Negative Pressure Wound Technology businesses. The portfolio of devices includes both durable medical equipment and single-use disposable sterile and non-sterile devices. 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 global product approvals. 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. In this role, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

Requirements

• 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 OR 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 AND
• 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
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

• 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.

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

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees