Regulatory Affairs Project Manager EMEA (CEOT & EAR)

***13 months fixed term maternity leave contract****

Regulatory Affairs Project Manager EMEA (CEOT & EAR)

A member of the Central RA team, a Regulatory Affairs Project Manager (Central Economic Operator Team) is responsible for the leadership and directing of complex projects (within the CEOT & EAR scope) which often require resources and functional integration for all aspects of the project from initiation to completion.

As part of the CEOT & EAR function this role is responsible with leading the verification activities for compliance to the European Medical Device Regulations (MDR) for Stryker products, developing and applying intermediate knowledge and understanding of RA frameworks, ensuring fulfilment of regulatory obligations and timely market access in EU countries.
Key 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.

• Manage project scope, deliverables, resources, schedules, and budgets; monitor 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.

• Lead and support project teams to improve performance, enhance collaboration, and ensure project efficiency.

• Preparation of briefings and other information documents with the ability to present to others.
   

Minimum Qualifications (Required):

• Educated to university degree level.

• 4 years’ relevant experience, experience within the medical device or similar industry preferred

Key requirements for the role:

• Regulatory experience or equivalent within a regulatory compliance function within a similar environment is preferred.

• Project managed 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.

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