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July 22 2018

    Job details


Job description:

   » Job ID.:15367107
   » Employer ID.:RI/47163
   » Published:10-JUL-2018
   » income:NEGOTIABLE
   » Job location:ROSCOMMON
   » Employment Type:PERMANENT


RA Admin/agent responsibilities
   » Change Control System / Document Control-Manage / Track change control, storage, release and distribution of all approved documents
   » contact 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 deal with and reply to any regulatory query.
   » Help to manage and maintain all RA documentation including Technical Master File RA Admin/agent practice:
   » Previous regulatory practice in a Medical Device manufacturing Facility
   » Strong computer expertise - Change control management; design, process and system.
   » Familiarity with ISO quality systems (MDD 93/42/EEC/MDR - ISO13485 – 21 CFR 820)
   » Good customer relation expertise
   » Risk Management including FMEA generation
For more information or to apply Contact Us by Tina Egan on 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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Job Category: Customer Service [ View All Customer Service Jobs ]
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Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Roscommon
Company Type Employer
Post Date: 07/10/2018 / Viewed 22 times
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