Regulatory Affairs Project Manager EMEA (Fixed term contract) at Stryker

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor's degree with an emphasis in management or related discipline or equivalent
4+ years relevant experience
Minimum of 1-2 years demonstrated project management experience
Preferred
Project management experience in medical devices
PMP certification or equivalent (i.e. PRINCE2)
Prior divisional or site experience desired

Responsibilities

Lead the execution of EMEA registration plans for assigned franchises, ensuring high-quality regulatory dossiers and timely approvals/renewals
Serve as primary contact with Stryker Design Divisions for market clearance and renewal activities, supporting ongoing market access aligned with business strategy
Collaborate with RAQA management and International RA teams to develop and execute submission strategies, share best practices, and optimize product registration processes
Participate in product lifecycle management planning and maintain RA execution throughout all phases of the product lifecycle
Manage project scope, deliverables, resources, schedules, and budgets; monitor performance, risks, and changes to ensure timely, efficient project completion
Lead, train, mentor, and motivate project teams to improve performance, enhance collaboration, and ensure project efficiency
Record and communicate customer requirements, constraints, and assumptions; align stakeholders through clear expectations and project plans
Analyze and monitor franchise registration activities, using appropriate tools to track performance, implement corrective actions, and support EMEA/Country RAQA teams
Develop, implement and maintain compliant, harmonised, best practice market clearance / registration processes across Europe, Middle East and Africa
Provide maturity and significant RA experience and expertise to the EMEA RAQA team to accelerate market access. Partner with the business by driving regulatory processes and activities through strategic projects

Skills

Project Management

Regulatory Affairs

Market Registration

RA Dossiers

Submission Strategies

Product Lifecycle Management

Stakeholder Management

Risk Management

RAQA

EMEA Regulations

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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