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Solventum

Enabling better, smarter, safer healthcare to improve lives.

Medical Writer – Clinical Compliance

Medical writerMedical writerFull TimeRemoteSeniorTeam 10,001+H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

91 days ago

Salary

$119.1K - $145.5K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

• 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.

Job 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

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