Staff Medical Writer (Remote) at Stryker

San Jose, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree (BA or BS) in a technical and/or scientific discipline
4+ years of Industry experience in medical technology or pharmaceuticals
2+ years of experience in Scientific or Medical Writing
Relevant academic or clinical research experience (PhD, Post-doc) (preferred)
Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) (highly preferred)
Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software (preferred)
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 (preferred)
Scientific and medical writing skills (preferred)
Knowledge of clinical operations, risk management, regulatory submissions and US and international guidelines (preferred)
Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation (preferred)

Responsibilities

Develop and complete 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 analyses, 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

Skills

Clinical Evaluation Reports

EU MDR

PMCF

Systematic Literature Reviews

Gap Analysis

Meta-Analyses

Regulatory Submissions

Medical Device Regulations

Clinical Evidence Synthesis

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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