Regulatory Affairs Specialist
Harmonics Recruitment
Limerick
We are currently recruiting for a unumber of roles across Regualtory Affairs from a junior to senior level. These are permanent positions, offering excellent benefits & negotiable salaries. General Responsibilities: Obtains and maintains an understanding global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 and become proficient / knowledgeable in global medical device regulations. Develop a thorough understanding of the medical devices they are assigned. Assist in the implementation of global regulatory strategies for the company’s medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), on all classes of devices. Plans and prepares regulatory submissions for specific target markets for new products, product changes and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability. Maintains registration information (license numbers, expiration dates, regulatory logs for annual reports, filing / printing of regulatory submissions, correspondence etc. Perform and maintain global regulatory restrictions in accordance with marketing authorizations. Communication with the Sister Companies, Distribution Partners and Regulatory Authorities to ensure product approvals are achieved in a timely manner. Serves as a liaison on regulatory issues between the Manufacturer and the International local office and/or distribution partner. Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required. Working with other functional units / departments in assessing changes to medical devices, determination of regulatory impact and communication to regulatory management. Assistance in procedure updates where required; circulation of change requests. Organizing documentation notarization, legalization / apostille with notary, Department of Foreign Affairs and relevant Embassies as appropriate for global registrations. Provides support to currently marketed products as necessary including input on change requests etc. Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations. Provides regulatory support to the functional units such as the SSC, tenders, customer quality and distribution. Education & Experience: Third level Qualification in Science/Engineering. At least 1 year experience in a regulated industry preferable but not essential. Basic knowledge / interest in Regulatory Affairs. Basic knowledge of medical device quality standards/practises or similar regulated industry. This job originally appeared on RecruitIreland.com.
2763 days ago