Cache of job #14015401

Job Title

Regulatory Affairs Specialist Opportunit

Employer

CPL

Location

Limerick

Description

Regulatory Affairs Specialist opportunities with global medical device company! These are contract roles, approximately 1 - 2 years duration. In this role you will help develop regulatory strategies and perform activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. Responsibilities will include the following: Plan and prepare regulatory submissions for specific target markets for new products, product changes and re-registrations as required. Maintain registration information (license numbers, expiration dates etc) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability. Ensure the biocompatibility requirements of the product are adequately addressed. Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed. Communicate directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner. Coordinate multiple projects at one time and provides regular reports to regulatory management and others as required. Applications are invited from candidates with the following background and experience: Third level Qualification preferably in Science/Engineering; plus a number of years’ experience in a regulated industry in a similar role desirable. Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required. Knowledge of medical device quality standards/practises or similar regulated industry. Knowledge of medical device quality standards/practises or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. Good computer skills including knowledge of Microsoft® Office. Proven organisational skills. High self-motivation. Willingness and availability to travel on company business. For more information and to apply for this role please call Deirdre on +353 1 2784671 or e-mail dbolger@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671. This job originally appeared on RecruitIreland.com.

Date Added

1815 days ago

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