Medical Writer - Clinical Compliance

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:

Medical Writer – Clinical Compliance

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.

The Impact You’ll Make in this Role

As a Medical Writer – Clinical Compliance, 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:

• Authoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs) to support new product introductions and existing products.

• 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.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) one of the following education and experience combinations:

• Bachelor’s degree or higher from an accredited institution AND three (3) years of experience in the medical device industry
   

OR

• High School Diploma/GED from an accredited institution AND seven (7) years of experience in the medical device industry

AND

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

• Three (3) years of experience in medical writing, preferably aligned to EU MDR clinical evaluation requirements

• Knowledge of relevant regulatory guidelines, including EU MDR, FDA, NMPA, and associated clinical evaluation processes

• Strong scientific writing and communication skills, with the ability to interpret and present clinical data

• Proficiency in Microsoft Office tools (Word, Excel, Outlook, PowerPoint)

• Demonstrated experience working on cross-functional teams in a global or regulatory environment

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

• Strategic and critical thinking, with the ability to solve problems and adapt to shifting priorities

• Familiarity with SSCP authoring and Class III/implantable medical device regulations in the EU

• Excellent attention to detail, time management, and organizational skills

Work location: Remote
Travel: No travel required
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