Regulatory Affairs Specialist - Permanent, Dublin North, Medical Devices.
Want to join a new operation set up?
Seeking to recruit a RA professional for our clients in the Medical Devices Manufacturing sector. We are delighted to bring another exclusive position to the Irish Market. Our clients are a global leader in developing and manufacturing healthcare medical device products and are suppliers to over 80 countries worldwide with their products. They are still expanding their European base and setting up a small manufacturing facility here in Ireland located in North Dublin.
Regulatory Affairs Specialist Responsibilities:
· Perform new product registration and upkeep of current products with relevant authorities
· Communicating with regulatory authorities as needed.
· Participation in Internal and External audits.
· Participate in risk assessments, primarily for ISO 13485.
· Day to day management of the QMS system.
· Writing and managing SOP’s and QMS documents.
· Management of complaints and vigilance
Regulatory Affairs Specialist Qualifications:
· Bachelor’s Degree or Ordinary Degree in Science or related field
· 1 to 2-years’ experience in Regulatory Affairs
· Experience with Quality Assurance will be an advantage
· Experience in new product registration
· Experience in dealing with regulatory authorities
· Experience in complaint handling and vigilance activities
· Experience in ISO:13485 will be an advantage
**FULL SPEC ON APPLICATION**
For a confidential discussion and more information on the role, please contact Tina Cornally.