Senior Regulatory Affairs Specialist (Remote - United States)

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Senior Regulatory Affairs Specialist

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. Here, 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 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

Your Skills and Expertise 

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• 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

In addition to the above requirements, the following are also required:

• 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

Additional qualifications that could help you succeed even further in this role include:

• 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.

Work location:

• Remote in the 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).

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 $131,750 - $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: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

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.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

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

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: 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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