Remote Senior Medical Writer – CER/PMCF Expert

Stryker; Seattle (WA); Remote; USD 110,000 - 238,000; Full time

Job summary

Stryker is hiring a Senior Staff Medical Writer to join the Endoscopy Division. This remote role supports the US market for regulatory and scientific documentation throughout the product lifecycle.

Based in the United States, you will author CERs, PMCF, and other clinical evidence documents, synthesize data from studies and literature, respond to regulatory feedback, and lead cross-functional writing initiatives with Regulatory, Clinical Affairs, and Quality teams.

Qualifications

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

Responsibilities

• Author and maintain CERs, PMCF, and other regulatory documents.
• Compile, analyze, and synthesize clinical evidence into submission-ready documents.
• Respond to notified body reviews and regulatory feedback to support market access.
• Collaborate with cross-functional teams to develop evidence strategies, regulatory plans, and timelines.
• Author clinical study protocols, study reports, data summaries, and supporting documents.
• Conduct systematic literature reviews and integrate findings into documentation.
• Lead document review cycles, coordinate stakeholder feedback, and obtain approvals.
• Drive continuous improvement and mentor junior medical writing team members.

Skills

Clinical writing

Regulatory docs

CERs PMCF

Literature reviews

Cross-functional

MDR knowledge

Education

Bachelor's degree

Master's degree (preferred)

Job description

Stryker is hiring a Senior Staff Medical Writer to join the Endoscopy Division. This remote role supports the US market for regulatory and scientific documentation throughout the product lifecycle.

Based in the United States, you will author CERs, PMCF, and other clinical evidence documents, synthesize data from studies and literature, respond to regulatory feedback, and lead cross-functional writing initiatives with Regulatory, Clinical Affairs, and Quality teams.