Cache of job #13952085

Job Title

Senior Regulatory Affairs Specialist

Employer

Brightwater

Location

Limerick

Description

Working at an innovation driven facility in Limerick you will assist in the running of the regulatory affairs team by providing input into regulatory strategies and by obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. Responsibilities: Assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required and other jurisdictions as required. Maintains an excellent understanding of the global medical device regulations. Maintains a thorough understanding of the products assigned to the team. Understands the progress of the RA team on assigned tasks, and removes roadblocks. Mentors and trains new RA team members. Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations. Reviews submissions generated for their assigned regulatory area to ensure compliance. Develops global regulatory strategies, especially on high risk devices. Advise other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and updates same on approval status in target markets. Ensures the biocompatibility requirements of the product are adequately addressed. Ensures the clinical requirements of the product are adequately addressed. Communicates status of projects / submissions directly to RA Management. Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner. Coordinates multiple projects at one time. Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability. Qualifications: Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable. Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required. 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.

Date Added

1990 days ago

Apply