Medical Writer - Clinical Compliance

SOLVENTUM•Remote - Wisconsin, WI

3d•$124,000 - $170,500•Remote

About The Position

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. 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 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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.
Corporate policies, procedures and security standards are complied with while performing assigned duties.