Stryker
Join to apply for the
Staff Medical Writer (Remote)
role at
Stryker .
We are currently seeking a
Staff Medical Writer
to join our
Sports Medicine Business Unit , part of the
Stryker Endoscopy Division . In this role, you will collaborate closely with cross‑functional teams, including Regulatory, Clinical, Quality, and Marketing to ensure the successful preparation of high‑quality, submission‑ready clinical documents. These include Clinical Evaluation Reports, Post‑Market Clinical Follow‑up documents, Summaries of Safety and Clinical Performance, and Clinical Study documentation.
Work Flexibility: Remote - can be based remotely anywhere within the United States.
What You Will Do
Responsible for the development and completion of Clinical Evaluation Reports (CERs) and post‑market clinical follow‑up (PMCF) documents for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs.
Compile clinical evidence from multiple sources such as current and past clinical trials, post‑market clinical follow‑up data and literature review updates, ad‑hoc analysis, meta‑analysis, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesize the information in support of EU‑MDR submissions, required CERs, and annual updates.
Perform systematic literature reviews for medical device groups or sub‑groups. Interpret literature information and synthesize the information in clinical regulatory documents.
Address notified body feedback on EU clinical documents and lead them to resolution for continued EU market access of the products.
Collaborate cross‑functionally to provide input for design teams for Clinical EU MDR documentation.
Assist with Clinical Evaluation Strategy for EU Market access.
For all documents, coordinate and manage the review process, and lead discussions on document revision.
Challenge conclusions when necessary. Independently resolve document content issues and questions from external and internal reviewers and ensure timely approvals from all reviewers.
Basic Qualifications
Bachelor’s degree (BA or BS) in a technical and/or scientific discipline required.
4+ years of industry experience in medical technology or pharmaceuticals, along with 2+ years of experience in scientific or medical writing, relevant academic or clinical research experience (PhD, Post‑doc).
Preferred Qualifications
Master’s or Ph.D. or other higher degree in a health‑related field (RN, BSN, BPharm/MD/MPH) is highly preferred.
Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software.
Knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents.
Scientific and medical writing skills.
Knowledge of clinical operations, risk management, regulatory submissions and US and international guidelines.
Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation.
Compensation and Benefits $87,600.00 - $186,700.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Posted: October 30, 2025.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance.
Job Details
Seniority Level: Associate
Employment Type: Full‑time
Job Function: Marketing, Public Relations, and Writing/Editing
Industries: Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing
#J-18808-Ljbffr
Staff Medical Writer (Remote)
role at
Stryker .
We are currently seeking a
Staff Medical Writer
to join our
Sports Medicine Business Unit , part of the
Stryker Endoscopy Division . In this role, you will collaborate closely with cross‑functional teams, including Regulatory, Clinical, Quality, and Marketing to ensure the successful preparation of high‑quality, submission‑ready clinical documents. These include Clinical Evaluation Reports, Post‑Market Clinical Follow‑up documents, Summaries of Safety and Clinical Performance, and Clinical Study documentation.
Work Flexibility: Remote - can be based remotely anywhere within the United States.
What You Will Do
Responsible for the development and completion of Clinical Evaluation Reports (CERs) and post‑market clinical follow‑up (PMCF) documents for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs.
Compile clinical evidence from multiple sources such as current and past clinical trials, post‑market clinical follow‑up data and literature review updates, ad‑hoc analysis, meta‑analysis, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesize the information in support of EU‑MDR submissions, required CERs, and annual updates.
Perform systematic literature reviews for medical device groups or sub‑groups. Interpret literature information and synthesize the information in clinical regulatory documents.
Address notified body feedback on EU clinical documents and lead them to resolution for continued EU market access of the products.
Collaborate cross‑functionally to provide input for design teams for Clinical EU MDR documentation.
Assist with Clinical Evaluation Strategy for EU Market access.
For all documents, coordinate and manage the review process, and lead discussions on document revision.
Challenge conclusions when necessary. Independently resolve document content issues and questions from external and internal reviewers and ensure timely approvals from all reviewers.
Basic Qualifications
Bachelor’s degree (BA or BS) in a technical and/or scientific discipline required.
4+ years of industry experience in medical technology or pharmaceuticals, along with 2+ years of experience in scientific or medical writing, relevant academic or clinical research experience (PhD, Post‑doc).
Preferred Qualifications
Master’s or Ph.D. or other higher degree in a health‑related field (RN, BSN, BPharm/MD/MPH) is highly preferred.
Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software.
Knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents.
Scientific and medical writing skills.
Knowledge of clinical operations, risk management, regulatory submissions and US and international guidelines.
Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation.
Compensation and Benefits $87,600.00 - $186,700.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Posted: October 30, 2025.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance.
Job Details
Seniority Level: Associate
Employment Type: Full‑time
Job Function: Marketing, Public Relations, and Writing/Editing
Industries: Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing
#J-18808-Ljbffr