Regulatory Affairs Project Manager EMEA (CEOT & EAR) at Stryker

Cork, County Cork, Ireland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Educated to university degree level
4 years’ relevant experience, experience within the medical device or similar industry preferred
Regulatory experience or equivalent within a regulatory compliance function within a similar environment is preferred
Project management experience with critical, abstract thinking and problem-solving skills
High attention to detail and process consciousness
Excellent interpersonal communication, collaborative teamwork and negotiation skills
Ability to build trusting relationships with mid-level management
Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organization, Design Divisions and third-party distributors

Responsibilities

Reviews technical documentation including labelling and instructions for use against EU MDR requirements and works with international manufacturing sites to resolve issues
Posts finalised technical documentation and review checklists to a central repository
Reports compliance metrics to the Sr Regulatory Affairs Manager, CEOT and works with the EMEA RAQA team to plan and deliver documentation reviews to specified timeframes
Escalates EU MDR regulatory compliance gaps and potential patient safety issues to the Sr Regulatory Affairs Manager, CEOT and international manufacturing sites in a timely manner
Supports the maintenance of EAR QMS
Provides support to the EMEA product registration team where required
Develops close collaboration with local RAQA teams across EMEA and international manufacturing sites to ensure timely documentation reviews and product release in EU countries
Performs based on established targets, KPIs and objectives for CEOT
Defines and communicates project scope, goals and deliverables for CEOT & EAR and Central RA projects
Records detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables
Ensures a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members
Leads the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle
Manages project scope, deliverables, resources, schedules, and budgets; monitors performance, risks, and changes to ensure timely, efficient project completion
Measures project performance using appropriate tools and techniques in order to maintain progress, communicate to stakeholders at regular intervals and perform any corrective actions as required
Leads and supports project teams to improve performance, enhance collaboration, and ensure project efficiency
Prepares briefings and other information documents with the ability to present to others

Skills

EU MDR

Regulatory Affairs

Technical Documentation Review

Project Management

QMS

Compliance Metrics

RAQA

Product Registration

Risk Management

Labelling Compliance

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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