Medical Writer - Clinical Compliance

Overview

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:  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.

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.

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

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

• 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…