Regulatory Affairs Specialist
Brightwater
Limerick
A key Medical Devices client in Munster requires 2 Regulatory Affairs professionals for maternity cover contracts. If you're looking to move to a progressive employer with an empowered work culture then this could be a fantastic move for you. Salary will be negotiable depending on experience. You'll need a strong background in Reg (Pharma or Medical Device) as you'll be expected to hit the ground running. Responsibilities: Maintain an excellent understanding of global medical device regulations e.g. ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820. Ensures a thorough understanding of the products they are assigned. Communicates country/region specific regulatory requirements to the regulatory specialists/ managers. Ensure the outputs from the individual functional units meet the applicable regulatory standards. Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations. Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability. Ensures biocompatibility of the products are adequately addressed. Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner. Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required. Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations. Qualifications / Experience: Third level Qualification preferably in Science/Engineering; 5 years experience in a regulated industry in a similar role desirable. Ideally have knowledge of GHTF countries including regulatory standards in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820. Good communication and inter-personal skills. Proven problem-solving skills. Proven organisational skills. High self-motivation. Approved External Auditor. Willingness and availability to travel on company business. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2332 days ago