Remote Senior Medical Writer, Endoscopy Regulatory Expert

Stryker; Phoenix (AZ); On-site; USD 110,000 - 238,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Employee stock purchase plan

Wellbeing program

Job summary

Stryker, a global medical technology leader, seeks a Senior Staff Medical Writer for the Endoscopy Division. The role is remote within the United States and focuses on authoring CERs, PMCF, and regulatory documents to support international registrations and lifecycle management.

Ideal candidates have 6+ years in medical technology and 4+ years in scientific writing, with strong knowledge of EU MDR and MDCG guidance.

Qualifications

• Bachelor’s degree in a scientific, technical, healthcare, or related discipline.
• Minimum 6 years of industry experience in medical technology, devices, or healthcare.
• Minimum 4 years in scientific/medical writing and regulatory documentation.
• Experience authoring CERs and PMCF documents.
• Knowledge of MEDDEV 2.7/1 Rev. 4, EU MDR, and MDCG guidance.
• Experience with systematic literature reviews and literature databases.

Responsibilities

• Author and maintain CERs, PMCF, and other regulatory documentation.
• Compile, analyze, and synthesize evidence for registrations and lifecycle management.
• Respond to notified body reviews and regulatory feedback.
• Collaborate with cross-functional teams on evidence strategies and timelines.
• Author study protocols, reports, and data summaries for regulatory initiatives.
• Conduct literature reviews and integrate findings into documents.
• Lead review cycles, coordinate feedback, and obtain approvals.
• Drive process improvements and mentor junior writers.

Skills

Clinical writing

Regulatory documentation

Literature reviews

Cross-functional collaboration

Mentoring

Education

Bachelor’s degree in a scientific field

Master’s degree or PhD (preferred)

Job description

Stryker, a global medical technology leader, seeks a Senior Staff Medical Writer for the Endoscopy Division. The role is remote within the United States and focuses on authoring CERs, PMCF, and regulatory documents to support international registrations and lifecycle management.

Ideal candidates have 6+ years in medical technology and 4+ years in scientific writing, with strong knowledge of EU MDR and MDCG guidance.