Project Manager Role Cork

Quality EUMDR Project Manager

  • Posted Jul 19, 2022
  • Cork
  • Contract
  • BBBH25142

LSC have a great contract opportunity for an Quality EUMDR Project Manager to join a multinational medical device company based in Cork.

If you have a Degree in Engineering and 8 to 10 years experience and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Shape and develop the Quality Make EU MDR Roadmap and Lead Global Implementation
  • Lead global quality team to develop EUMDR rollout plan in collaborating with engineering site representative and global EUMDR team for key aspect such as:
  • Article 18 implementation (new implant cards & labeling requirements) - develop best global strategy and lead site implementation though quality team globally
  • Understand Multivariant EUMDR strategy and assess impact globally & ensure overall business initiatives interdependences understood, with communication to site stakeholders as required to align position
  • Ensure all quality deliverables met to achieve successful submission to notified bodies per committed timelines and requirements
  • Provide executive summary updates to key stakeholders such at Joints; Franchise; and Quality Make Leadership teams as well at the EUMDR leadership team
  • Review & ensure QS procedures and controls are in compliance to standards such as the QSRs, ISO 13485, etc and comply with the recognized Regulatory Standard
  • Communicate executive summary to broad stakeholder Leadership teams of EUMDR; Joints; Franchisee; Quality. Propose solutions/roadmaps to any new emerging challenges and influence leadership teams to support as needed

ABOUT YOU - ARE YOUR SKILLS A MATCH?

  • Good knowledge of product/process Risk Management (FDA and ISO standards) is required
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
  • EU MDR knowledge and understanding is preferred
  • Ability to manage resources remotely.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!

Apply via this advert or contact Ellen Farley on 0214777329 if you have any more questions about this brilliant opportunity!

This could be the perfect project for you! Apply online and we’ll be in contact shortly

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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