Senior Medical Writer (remote)

Arthrex Inc

Remote, United States
Not specified; annual bonus available; comprehensi...
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Eu mdr/mdd regulatory experience
Clinical evaluation report writing
Systematic literature reviews
** Arthrex Inc is seeking a Senior Medical Writer to join their remote team, focusing on regulatory documentation for medical devices. The ideal candidate will have substantial experience in clinical medical writing, particularly with EU MDR/MDD experience, to support regulatory submissions and compliance. **

Job Summary

  • This role is critical for supporting regulatory approval efforts for international markets within the orthopedic medical device sector.
  • The successful candidate will specialize in writing, editing, and reviewing clinical regulatory documents such as CERs, CEPs, and PSURs.
  • Arthrex offers a comprehensive benefits package including matching 401(k), paid parental leave, and tuition reimbursement.

Matching Summary

Match Score: 75

** Arthrex Inc is seeking a Senior Medical Writer to join their remote team, focusing on regulatory documentation for medical devices. The ideal candidate will have substantial experience in clinical medical writing, particularly with EU MDR/MDD experience, to support regulatory submissions and compliance. **

Salary

Not specified; Annual bonus available; Comprehensive benefits including medical, dental, vision, and 401(k) match

Skills & Requirements

Must-have

  • EU MDR/MDD regulatory experience
  • Clinical Evaluation Report writing
  • Systematic literature reviews
  • Post-market surveillance documentation
  • Cross-functional team collaboration

Nice-to-have

  • Experience with international market clearance
  • Strong analytical reasoning skills
  • Ability to manage multiple concurrent projects
  • Proficiency in SAP and Microsoft Office Suite

Key Requirements

  • Bachelor's degree in Life Science or related discipline
  • 5 years of relevant clinical medical writing experience
  • Required EU MDR/MDD experience

Work Rights

Not specified

Tailored Resume

Cover Letter