- Reference: 47163
- Job Type: Permanent
- Location: Galway, Roscommon, Westmeath
- Category: Science, Pharmaceutical & Food
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 firstname.lastname@example.org 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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