Medical Writer – Clinical Compliance
Solventum
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $119,076 - $145,537 per year
Job Level
Mid-LevelSenior
About the role
- 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.)
- 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
Benefits
- Medical
- Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical evaluation plansclinical evaluation reportsmedical writingtechnical writingdata analysisregulatory complianceclinical data assessmentsafety and clinical performance reportsEU MDRFDA
Soft skills
collaborationcommunicationscientific writinginterpretation of data
Certifications
Bachelor’s degreeaccredited institution