Medical Writer - Clinical Compliance

Job Description:

Medical Writer - Clinical Compliance (Finance). Solventum is a new healthcare company with a long legacy of solving big challenges to improve lives and help healthcare professionals perform at their best. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges.

• 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.

• Bachelor's degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Engineering, 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 efficiency.

Remote - United States

May include up to 10% domestic.

Not authorized.

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

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 $119,076 – $145,537, 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 such as, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience.

Responsibilities of this position include compliance with corporate policies, procedures, and security standards 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. 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 uploading a resume or by entering the information into the application fields directly.

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