Senior Regulatory Affairs Specialist (Hybrid) at Stryker

Redmond, Washington, 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 in an Engineering, Science, or equivalent field
Minimum of 3 years of experience in an FDA or highly regulated industry
Minimum of 2 years in a Regulatory Affairs role
Preferred: RAC certification or Advanced Degree (Masters in Regulatory Affairs)
Preferred: Previous experience with US Class II/III medical devices
Preferred: Experience authoring regulatory submissions for product approval
Preferred: Experience interacting with regulatory agencies

Responsibilities

Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers
Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
Assist in the development of regulatory strategy and update strategy based upon regulatory changes
Evaluate proposed products for regulatory classification and jurisdiction
Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products
Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools
Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions
Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process
Maintain current product registrations and assist with processing registration changes when required

Skills

FDA Regulations

Regulatory Submissions

Regulatory Strategy

Medical Devices

Product Registration

Regulatory Compliance

Regulatory Assessments

Market Access

Product Lifecycle 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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