Regulatory Affairs Manager required by growing medical devices company in Clare to manage an RA team & ensure compliance with various medical devices regulations. 

Responsibilities:

• Manage RA personnel
• Ensure that relevant global Regulatory Compliance requirements are identified, defined, documented, implemented, complied with, and sustained, including product safety requirements for the markets served
• Ensure compliance with the following medical device & software quality requirements: EU Medical Device Directive and Medical Device Regulation guidelines and associated QSRs, such as the MEDDEVs
  ISO13485 Medical Device QMS
  MDSAP program member Quality System Regulations & associated documents
  US FDA 21 CFR Part 11 guidance
  ICH E6 GCP
• Facility & device registering, licencing and device change management etc., within applicable jurisdictions, including supporting licence holders with documentation etc. Assure conformity of devices is appropriately checked, in accordance with the documented QMS under which the devices are manufactured, before a device is released

Requirements: 

• Minimum BSc/BEng degree in a science or technical discipline with a relevant postgraduate qualification a distinct advantage
• Have completed post-qualification quality and regulatory training
• Minimum 10 years’ experience in medical device quality and/or regulatory areas
• In-depth understanding of FDA Class II and EU MDD / MDR class IIa medical device requirements and regulations
• Experience of implementing and maintaining ISO 13485
• Experience of hosting regulatory body notified body and customer audits
• Interpersonal skills and professional skills to interact at all levels including senior management, contractors and colleagues
• People management and supervisory experience
• Experience of ICH E6 GCP requirements would be an advantage
• Strong problem-solving and analytical skills