Skip to main contentA logo with &quat;the muse&quat; in dark blue text.

Senior RA Project Manager, EMEA

AT Stryker
Stryker

Senior RA Project Manager, EMEA

Newbury, United Kingdom

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Position Summary

Under general direction, responsible for the leadership and directing of complex projects, which often require resources and functional integration. Responsibility for all aspects of the project from initiation to completion.

Want more jobs like this?

Get Project Management jobs in Newbury, United Kingdom delivered to your inbox every week.

By signing up, you agree to our Terms of Service & Privacy Policy.


Interfaces with all stakeholders affected by the project, including end users.

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.

Key Activities & Accountabilities

  • Leads the execution and delivery of the EMEA registration plan for assigned franchises and building high quality regulatory dossiers to achieve timely regulatory approvals and renewals.
  • Primary contact with assigned Stryker Design Divisions on market clearance and renewal activities, ensuring ongoing market access in line with business strategy.
  • Supports the execution of submission strategies / registration planning in EMEA in collaboration with RAQA management.
  • Maintain active participation in product lifecycle management planning and associated RA execution.
  • Build, implement and maintain effective product registration processes.
  • Partner with International RA teams to promote sharing of best practice and leveraging of product documentation to accelerate market access.
  • Analyse and monitor registration activity for all franchises on a periodic basis to ensure performance is in line with objectives and communicate performance to RAQA management.
  • Understanding of RA /QA / PMS procedures and processes.
  • Able to define and communicate project scope, goals and deliverables
  • Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project
  • Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables
  • Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle
  • Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members
  • Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle
  • Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance
  • Responsible to improve team performance by building team cohesiveness, leading, influencing, training, mentoring, and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale
  • Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders
  • May coordinate the activities of one or more exempt and/or non-exempt employees
  • Provides support to EMEA / Country RAQA teams as appropriate

Education

BA or BS (emphasis in management or related discipline preferred) or equivalent

Experience

Minimum of 6 years demonstrated project management experience in Regulatory Affairs preferred

PMP certification or equivalent (i.e. PRINCE2) desired

Prior divisional or site experience desired

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.

Client-provided location(s): Newbury, UK
Job ID: Stryker_Combined-hO18eP351ekp
Employment Type: Other

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • FSA With Employer Contribution
    • HSA
    • HSA With Employer Contribution
    • On-Site Gym
    • Mental Health Benefits
    • Virtual Fitness Classes
  • Parental Benefits

    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
    • On-site/Nearby Childcare
  • Work Flexibility

    • Flexible Work Hours
    • Remote Work Opportunities
    • Hybrid Work Opportunities
    • Work-From-Home Stipend
  • Office Life and Perks

    • Casual Dress
    • Happy Hours
    • Company Outings
    • Commuter Benefits Program
    • Snacks
    • Some Meals Provided
    • On-Site Cafeteria
    • Holiday Events
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Personal/Sick Days
    • Sabbatical
    • Leave of Absence
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Company Equity
    • Stock Purchase Program
    • Performance Bonus
    • Relocation Assistance
    • 401(K)
    • Financial Counseling
  • Professional Development

    • Tuition Reimbursement
    • Learning and Development Stipend
    • Promote From Within
    • Mentor Program
    • Shadowing Opportunities
    • Access to Online Courses
    • Lunch and Learns
    • Internship Program
    • Work Visa Sponsorship
    • Leadership Training Program
    • Associate or Rotational Training Program
  • Diversity and Inclusion

    • Diversity, Equity, and Inclusion Program
    • Employee Resource Groups (ERG)

Company Videos

Hear directly from employees about what it is like to work at Stryker.