Senior Medical Writer - Remote (CERs & PMCF)

PowerToFly; Portland (OR); Remote; USD 110,000 - 238,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker in the United States is seeking a Senior Staff Medical Writer for the Endoscopy Division, to be based remotely across the U.S. You will develop scientific and regulatory documents to support global registrations and lifecycle management.

You will work with Regulatory, Clinical, Quality, RD, and Marketing to translate complex evidence into submission-ready materials. Requires 6+ years in medical technology and 4+ years in medical writing, with CER/PMCF experience.

Qualifications

• Bachelor’s degree in a scientific/healthcare field.
• 6+ years in medical technology or healthcare products.
• 4+ years in scientific/medical writing or regulatory docs.
• Experience with CERs and PMCF documentation.
• Knowledge of MEDDEV 2.7/1 Rev.4, EU MDR 2017/745.
• Experience systematic literature reviews and databases.
• Knowledge of FDA, GCP, ISO 14155/14971.

Responsibilities

• Author and maintain CERs, PMCF, and other regulatory docs.
• Synthesize clinical evidence from studies, literature, and post-market data.
• Respond to regulatory reviews and drive resolution of questions.
• Collaborate with Regulatory, Clinical, Quality, RD, and Marketing teams.
• Author protocols, study reports, data summaries, and regulatory documents.
• Conduct systematic literature reviews and integrate findings.
• Lead document review cycles and obtain approvals.
• Drive process improvements and mentor junior writers.

Skills

Scientific writing

Regulatory documentation

Clinical evidence synthesis

Cross-functional collaboration

Medical writing leadership

Education

Bachelor’s degree in scientific/healthcare field

Master’s degree or higher (preferred)

Job description

Stryker in the United States is seeking a Senior Staff Medical Writer for the Endoscopy Division, to be based remotely across the U.S. You will develop scientific and regulatory documents to support global registrations and lifecycle management.

You will work with Regulatory, Clinical, Quality, RD, and Marketing to translate complex evidence into submission-ready materials. Requires 6+ years in medical technology and 4+ years in medical writing, with CER/PMCF experience.