Regulatory Affairs Officer
Our Client, a Class I medical device manufacturer, is currently looking for a Regulatory Affairs Officer to join their organisation. Reporting to the Operations Director, the role holder will play a key part in ensuring ongoing compliance to ISO 13485:2016 and the Medical Device Regulations.
Responsibilities
Perform compliance gap assessment on all technical files identifying amendments required to ensure compliance with current Medical Device Directive [MDD], ISO13485:2016 and new Medical Device Regulation [MDR]
Manage the process of ensuring all gaps identified are actioned and completed by relevant departments within agreed timeframes
Prepare documentation for regulatory submission
Create and manage SOPs, quality records, CAPA’s, complaints, change orders, management reviews, post-market surveillance.
Respond to all queries from customers related to product performance and quality
Lead the preparations for, and hosting of, external audits from Regulatory Authorities
Manage the internal audit program
Proactively participate in QC Continuous Improvement projects
Liaise with other departments on Quality issues providing guidance and support as required
Qualifications, Experience, Skills Required
Third level qualification in Engineering/ Quality/ Science
Minimum of 3 years experience in the medical device industry in a Quality role
Excellent working knowledge of ISO13485:2016 and Medical Devices Directive
Strong project management and organisational skills
A high level of initiative
Ability to adapt to changing priorities