Senior Staff Clinical Evaluation Specialist (Remote) at Stryker

Ottawa, Ontario, Canada

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Master of Science degree in a health/science-related field required
Doctorate degree in health/science-related field preferred
6+ years of industry experience in clinical, quality, or regulatory affairs (risk management, design quality, post-market safety, etc.)

Responsibilities

Act as the dedicated clinical evaluation project manager, driving the establishment of a coherent clinical evidence strategy throughout the new product development cycle
Foster alignment with adjacent processes (e.g., marketing strategy and claims, regulatory strategy, clinical research strategy, preclinical testing strategy)
Write/revise documents for regulatory submissions, pre-subs, annual reports, clinical evaluations, post-market clinical follow-up, summary of safety and clinical performance, post-market surveillance, and clinical studies to validate device safety and performance
Identify, appraise, and analyze relevant clinical, post-market surveillance, marketing, and preclinical testing data to create comprehensive scientific reviews, which may include in-depth quantitative analyses, qualitative analyses, and risk management cross-checks
Synthesize information in clinical documents in a clear, concise, and scientifically accurate manner
Maintain documentation throughout the product lifecycle
Design compliant and sustainable literature search strategies, perform systematic reviews to capture and summarize published clinical data
Form and justify conclusions regarding the overall benefit-risk profile of medical devices, in collaboration with a medical expert and other stakeholders, based on up-to-date US, European, and other regulatory requirements
Communicate and negotiate with regulators on clinical evidence requirements to ensure the successful acceptance of regulatory submissions
Analyze current medical and scientific trends in the clinical state of the art on a broad variety of specialized indications and techniques
Lead evidence communication in partnership with stakeholders (e.g., Marketing, Clinical Research, Reimbursement & Market Access) to ensure alignment with business priorities
Translate complex scientific and technical information into accessible content for various audiences, including regulatory bodies and customers
Create publication plans supporting key products
Prepare documents like manuscripts, conference presentations/posters, white papers, and customer-facing promotional materials
Assist customers with manuscript/presentation preparation
Support clinical research activities by identifying gaps in knowledge and developing strategies for pre-clinical and clinical data collection
Support new product development projects by helping cross-functional teams develop intended use and indication for use statements, risk files, and product claims
Support sustainment projects to ensure continued product availability
Help translate clinical data into new claims for existing products
Review marketing collateral for accuracy of clinical information, product performance, and safety claims
Proactively recognize potential scheduling and resource conflicts for projects and provide recommendations to resolve
Identify and implement new strategies to enhance team efficiency
Independently resolve document content issues and questions from external and internal reviewers
Coordinate and manage the cross-functional review process and ensure timely approvals from all reviewers
Foster open dialogue and actively challenge conclusions when needed to ensure what’s best for customers

Skills

Clinical Evaluation

Regulatory Submissions

Post-Market Surveillance

Literature Search

Systematic Reviews

Risk Management

Benefit-Risk Analysis

Medical Device Regulations

Clinical Research

Project Management

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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