Senior Staff Medical Writer (Remote)

Stryker Corporation; Northern (KY); Remote; Confidential; Full time

Job summary

Stryker Corporation is seeking a Senior Staff Medical Writer to join the Endoscopy Division. This remote role allows you to work from anywhere in the United States with 10% travel.

You will author CERs, PMCF documents, and regulatory submissions, and collaborate across teams to shape clinical evidence strategies. Ideal candidates have 6+ years in medical technology and 4+ years in scientific writing, with strong EU MDR, MDCG guidance, and FDA/GCP knowledge.

Qualifications

• Bachelor’s degree in a scientific, technical, healthcare, or related discipline.
• Minimum 6 years of experience in medical technology, medical devices, or healthcare products.
• Minimum 4 years in scientific writing, medical writing, clinical research, or regulatory documentation.
• Experience authoring CERs and PMCF documentation.
• Expert knowledge of MEDDEV 2.7/1 Rev. 4, EU MDR 2017/745, and MDCG guidance.
• Experience conducting systematic literature reviews and using literature databases.
• Knowledge of FDA, GCP, ISO 14155, ISO 14971, and applicable international medical device regulations.

Responsibilities

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

Skills

Scientific writing

Regulatory documentation

Clinical evaluations

CER writing

EU MDR knowledge

Regulatory submissions

Literature reviews

FDA/GCP compliance

Education

Bachelor’s degree in science/healthcare

Tools

Literature databases

Job description

Work Flexibility

Remote Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based remotely anywhere within the United States. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. Our Endoscopy Division delivers a diverse array of innovative medical technologies to support minimal invasive surgery through brilliant visualization, connected OR solutions, sports medicine products to sustainability solutions.

What You Will Do

• Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) documents, and other clinical evidence documentation supporting international product registrations and lifecycle management.
• Compile, analyze, and synthesize clinical evidence from clinical studies, published literature, post‑market data, and other safety and performance sources into submission‑ready regulatory documents.
• Respond to notified body reviews and regulatory feedback, driving resolution of clinical documentation questions to support ongoing market access.
• Collaborate with cross‑functional teams to develop clinical evidence strategies, regulatory documentation plans, and project timelines.
• Author clinical study protocols, study reports, data summaries, and supporting scientific documents for regulatory and clinical initiatives.
• Conduct systematic literature reviews, evaluate scientific data, and integrate findings into clinical and regulatory documentation.
• Lead document review cycles, coordinate stakeholder feedback, resolve content issues, and obtain timely approvals.
• Drive continuous improvement initiatives, maintain medical writing tools and templates, and mentor junior medical writing team members.

What You Need

• Required: Bachelor’s degree in a scientific, technical, healthcare, or related discipline.
• Minimum 6 years of industry experience within medical technology, medical devices, pharmaceuticals, or healthcare products.
• Minimum 4 years of experience in scientific writing, medical writing, clinical research, or related regulatory documentation activities.
• Experience authoring Clinical Evaluation Reports (CERs) and Post‑Market Clinical Follow‑Up (PMCF) documentation.
• Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745), and Medical Device Coordination Group (MDCG) guidance for clinical evaluations.
• Experience conducting systematic literature reviews and utilizing scientific databases, literature search methodologies, and literature management tools.
• Knowledge of FDA, Good Clinical Practice (GCP), ISO 14155, ISO 14971, and applicable international medical device regulations and standards.
• Preferred: Master’s degree, PhD, PharmD, MD, MPH, RN, BSN, or other advanced health‑related degree.
• Experience authoring clinical study protocols, clinical study reports, manuscripts, or scientific publications.
• Experience supporting regulatory submissions and global market access initiatives for medical devices.
• Knowledge of clinical operations, risk management, and international regulatory requirements.

United States of America Pay Ranges

• USN: $110,100 - $183,400 USD Annual
• US5: $115,600 - $192,600 USD Annual
• US10: $121,100 - $201,700 USD Annual
• US15: $126,600 - $210,900 USD Annual
• US20: $132,100 - $220,100 USD Annual
• US30: $143,100 - $238,400 USD Annual

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co‑located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.