LSC have a great contract opportunity for a Senior Quality/Regulatory Specialist to join a leading medical device in Cork.
If you have 5 plus years’ experience in Quality Assurance and/or regulatory affairs in the Medical Device or Pharmaceutical Industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
Support Central product assortment
o Works with procurement to advise and determine product and customer requirements for new Own Label products.
o Ensure product and packaging specification conforms to EU standards.
Quality System Support
o Assists maintain the necessary ISO13485 Quality System for importation of medical devices into the EU.
o Maintain QA documentation in accordance with cGMP (current Good Manufacturing Procedures) and ISO 13485 standard requirements.
o Completes and submits regulatory reports within the timeframes mandated by the regulations.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Degree level in science/engineering
o Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485:2016, ISO 14971 and ISO10993 series); knowledge of Cosmetics and Food supplement regulation is a plus.
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!
To apply, submit your CV via this advert or contact Katie Browne at LSC on 021-4777329 if you have anymore questions about this Senior Quality/Regulatory Specialist opportunity!