Associate Manager, Regulatory Affairs at Stryker

Redmond, Washington, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s Degree required, preferably in Science or Engineering
6+ years of related experience, preferably within a regulated industry such as medical device, pharmaceutical, biotechnology, or other highly controlled environments
3+ years of Quality or Regulatory Affairs experience
Previous experience in a technical function (i.e., Engineering, Quality, Clinical, Pre or Post Market Regulatory, Manufacturing)
Preferred: Prior supervisory experience
Preferred: Advanced degree or RAC Certification

Responsibilities

Establish a regulatory center of excellence, develop organizational strategies, processes, goals, and metrics to drive measurable improvement in regulatory processes and oversee consistency of regulatory processes
Drive new approaches to improve the development, review, and oversight of healthcare products
Lead and contribute to regulatory initiatives, including the development of good regulatory practices, policies, and advocacy activities
Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met
Oversee daily regulatory operations to ensure effective issue evaluation and resolution, serving as the subject matter expert and chairing key meetings to drive closure of regulatory issues
Provide strategic guidance and implementation plans for compliance with evolving regulatory requirements
Establish standard processes to ensure appropriate resolution and management of the responsible task owner
Develop and manage budgets, quarterly forecasts, and regulatory metrics, including tracking and reporting
Represent regulatory processes during internal and external audits and drive continuous enhancement
Define targets, KPIs, performance objectives for individuals within functional role, and manage direct reports to meet or exceed these targets
Build and lead a high-performing team by fostering engagement, developing talent, and cultivating a culture of accountability and growth

Skills

Regulatory Strategies

Global Registrations

Regulatory Submissions

Regulatory Compliance

Audits

Budget Management

Process Improvement

Team Leadership

Stakeholder Collaboration

KPIs

Quality Assurance

R&D Collaboration

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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