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!