EU MDR Medical Writer: CERs, CEPs & PMCF Reports

Kelly Science, Engineering, Technology & Telecom; California; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401K

Paid time off options

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking a Medical Writer for a long-term role with a Global Medical Device client. You will assist in planning and executing medical writing activities related to EU MDR compliance, including clinical documents like Clinical Evaluation Reports (CERs).

The ideal candidate will have a degree, 5 years of experience in medical writing, and proficiency in Microsoft Office Suite. This full-time position includes comprehensive benefits and paid time off options.

Qualifications

• 5 years of related job experience in medical or scientific writing.
• 3-5 years experience in the medical device industry and CER document creation.
• Strong oral communication, project management, and prioritization skills.

Responsibilities

• Prepare clinical research documents for medical device registrations.
• Communicate with clinical scientists and project managers to ensure document accuracy.
• Conduct literature searches and summarize pertinent clinical literature.

Skills

Medical writing

Regulatory compliance

Clinical research

Statistical analysis

Project management

Education

BA, BS or BSN

Advanced science degree (MS, PhD, OD)

Tools

Microsoft Office Suite

Distiller

Bibliographic software (e.g., Endnote)

Job description

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