Senior Medical Writer, Regulatory & Clinical (Remote)

PowerToFly; Oregon (WI); Remote; USD 110,000 - 190,000; Full time

Benefits offered by this job

Health benefits

Remote work within US

Job summary

Stryker is hiring a Senior Staff Medical Writer for its Endoscopy Division. This remote, nationwide role focuses on developing regulatory and scientific documents to support global registrations and lifecycle management of medical devices.

You will translate complex clinical evidence into CERs, PMCF, and other submissions, coordinating with Regulatory, Clinical, and Quality teams while mentoring junior writers. A strong background in medical writing and regulatory standards is required.

Qualifications

• CERs and PMCF documentation experience
• Knowledge of MEDDEV 2.7/1 Rev. 4, EU MDR 2017/745, MDCG guidance
• Experience conducting systematic literature reviews
• Familiarity with FDA, GCP, ISO 14155, ISO 14971 and international medical device regs

Responsibilities

• Author and maintain CERs, PMCF and other regulatory documents
• Synthesize clinical evidence from studies and literature 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
• Lead document review cycles and coordinate approvals
• Mentor junior medical writing team members
• Maintain medical writing tools and templates

Skills

Medical writing

Clinical evidence

Regulatory documentation

Literature reviews

Cross-functional collaboration

Regulatory standards

Education

Bachelor's degree

Master's degree (preferred)

Job description

Stryker is hiring a Senior Staff Medical Writer for its Endoscopy Division. This remote, nationwide role focuses on developing regulatory and scientific documents to support global registrations and lifecycle management of medical devices.

You will translate complex clinical evidence into CERs, PMCF, and other submissions, coordinating with Regulatory, Clinical, and Quality teams while mentoring junior writers. A strong background in medical writing and regulatory standards is required.