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Job Title

Regulatory Affair Officer

Employer

Collins Mcnicholas Recruitment

Location

Roscommon

Description

RA Admin/Officer responsibilities. Change Control System / Document Control-Manage / Track change control, storage, release and distribution of all approved documents. Liaise with all departments to ensure continued corporate compliance. Support Management review and Management of external 3rd party audits. Provide Regulatory support to new product introduction and product transfers teams. Ensures the biocompatibility requirements of the product are adequately addressed. Ensures the clinical requirements of the product are adequately addressed. Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations. Support all Product design and process changes requiring regulatory support. Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same. Review and approve all related change orders and perform the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements. Provide support to solve and reply to any regulatory query. Help to manage and maintain all RA documentation including Technical Master File. RA Admin/Officer experience: Previous regulatory experience in a Medical Device manufacturing Facility. Strong computer skills - Change control management; design, process and system. Familiarity with ISO quality systems (MDD 93/42/EEC/MDR - ISO13485 – 21 CFR 820. Good customer relation skills. Risk Management including FMEA generation. For more information or to apply please contact Tina Egan on tina.egan@collinsmcnicholas.ie 09064 78104. Please Note: Collins McNicholas will not forward your details to any company without your prior approval. Setting the Standards for Excellence in Recruitment. To see a full list of jobs available across Ireland please visit our website atwww.collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.

Date Added

2066 days ago

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