Medical Writer - Clinical Compliance

Job Description Medical Writer – Clinical Compliance (Solventum) 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.

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.

• Authoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs), to support new product introductions and sustaining product activities in the Dental Solutions business unit.
• Collaborating with cross-functional teams to collect, analyze, and assess clinical data in compliance with EU MDR and other global regulatory requirements.
• Supporting internal and external audits as a subject matter expert in clinical evaluations.
• Maintaining up-to-date clinical evaluations across the full lifecycle of medical devices.
• Contributing to Summary of Safety and Clinical Performance (SSCP) reports and regulatory responses with guidance from manager/supervisor.

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 from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND five (5) years of experience in the medical device industry

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

• Minimum of five (5) years of experience in medical writing or technical writing in a regulated industry, preferably aligned to EU MDR requirements

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

• Strong scientific writing and communication skills, with the ability to interpret and present clinical data
• Dental experience in a private, public, government or military environment
• Demonstrated experience working on cross-functional teams in a global or regulatory environment
• Familiarity with SSCP authoring and Class III/implantable medical device regulations in the EU
• Excellent attention to detail, time management, and organizational skills
• Ability to manage multiple complex projects simultaneously
• Strategic thinking, critical thinking, reasoning, and interpretive skills
• Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills.
• Experience utilizing AI technologies to optimize workflows, automate tasks, and enhance operational efficiency.

Work location: Remote – United States

Travel: May include up to 10% domestic

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 $124,000 - $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…