Senior Medical Writer: Regulatory & Clinical Docs (Remote)

PowerToFly; Los Angeles (CA); Remote; USD 110,000 - 238,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Job summary

Stryker is hiring a Senior Staff Medical Writer for the Endoscopy Division, remotely anywhere in the United States. The role focuses on developing regulatory and clinical documentation to support global registrations and lifecycle management, partnering with Regulatory, Clinical, Quality, R&D, and Marketing teams to translate evidence into high-quality documents.

You will author CERs, PMCF, study protocols and reports, conduct literature reviews, and drive document reviews through timely

Qualifications

• Bachelor’s degree in a scientific, technical, healthcare, or related discipline.
• Minimum 6 years of industry experience in medical technology, medical devices, pharmaceuticals, or healthcare products.
• Minimum 4 years of experience in scientific writing, medical writing, clinical research, or regulatory documentation activities.
• Experience authoring Clinical Evaluation Reports (CERs) and PMCF documentation.
• Expert knowledge of MEDDEV 2.7/1 Rev. 4, EU MDR 2017/745, and MDCG guidance.

Responsibilities

• Author and maintain CERs, PMCF, and other clinical evidence documentation for regulatory submissions.
• Compile and synthesize clinical evidence from studies, literature, and data into submission-ready documents.
• Respond to regulatory feedback and drive resolution for market access.
• Collaborate with Regulatory, Clinical, Quality, R&D, and Marketing on evidence strategies and timelines.
• Author protocols, study reports, data summaries, and scientific documents for regulatory initiatives.
• Conduct systematic literature reviews and integrate findings into regulatory documentation.
• Lead document reviews, coordinate stakeholder feedback, and obtain approvals.
• Drive continuous improvement, maintain writing tools and mentor junior staff.

Skills

Scientific writing

Regulatory documentation

Cross-functional collaboration

Regulatory standards knowledge

Education

Bachelor's degree in a scientific/healthcare discipline

Job description

Stryker is hiring a Senior Staff Medical Writer for the Endoscopy Division, remotely anywhere in the United States. The role focuses on developing regulatory and clinical documentation to support global registrations and lifecycle management, partnering with Regulatory, Clinical, Quality, R&D, and Marketing teams to translate evidence into high-quality documents.

You will author CERs, PMCF, study protocols and reports, conduct literature reviews, and drive document reviews through timely