Regulatory Affairs Officer

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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

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