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Regulatory Affairs Specialist

Location: Cork Salary:
Sector: Medical Devices, Regulatory Affairs (RA) Type: Contract

I am working with one of the world's leading medical technology companies, they are currently seeking a regulatory affairs specialist for an 8 week contract.

Role: Regulatory Affairs Specialist

Contract: 8 week contract

Location: Cork

Job Description

  • Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes.
  • Supports the product lifecycle through to obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.
  • Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.
  • Viewed as regulatory team resource.
  • Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
  • Assisting in SOP development and review
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively
  • Ability to communicate and network with regulatory personnel to obtain relevant information

Qualifications

  • B.Sc in Engineering, Sciences or equivalent preferred
  • 1-3 years regulatory experience in the medical device or pharmaceutical industry
  • RAC certification (preferred)
  • Knowledge of the Quality System Regulations (21 CFR), Medical Device Directives (MDD) and MEDDEV guidance

This is an excellent opportunity for an experienced Regulatory Affairs Specialist who is looking for a role in Cork.

For immediate consideration please apply with an up to date CV. Not sure yet? No CV ready? Give me a call for more information

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales