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Senior Regulatory Affairs Specialist

Role: Regulatory Affairs Specialist

Location: Cork

Contract: 6 months - daily rate contract

As a Regulatory Affairs Specialist, you will support new product development, by contributing to the development and updating of regulatory strategy based upon regulatory changes. You will also be responsible for ensuring Regulatory Compliance.

Responsibilities:

  • Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
  • Assisting in the development and update of regulatory strategy based upon regulatory changes.
  • Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.
  • Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications.
  • Identifying issues early in the submission preparation process that could impact product launch.
  • Compiling, preparing, reviewing and submitting regulatory dossiers to authorities.
  • Reviewing product claims and preserving confidentiality of applicable product information.

Requirements:

  • 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 a Regulatory Affairs Specialist who is seeking new opportunities in Cork.

No CV ready? Not sure yet? Give me a call to find out 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