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Search Results for Regulatory Affairs Consultant
Job Title. Location Salary Actions

Regulatory Affairs Specialist

RA Specialist Our client, a respected medical device company are currently recruiting a RA Specialist who will be responsible for regulatory support for operations, product development and quality to ensure that the product is in compliance with all internal and external regulatory requirements. As RA Specialist, you will: Participate in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory submissions plan around product development...

Location: Wexford,
Regulatory Affairs Specialist 		Wexford Not Disclosed
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Regulatory Affairs Consultant Career Profile

Regulatory Affairs Consultant


Whether it's working in a solo-operation, or in a Regulatory Consultancy, working as a consultant can give flexibility and great challenges to a Regulatory expert with a number of years in industry.

Key Responsibilities

  • Timely preparation and submission variations and renewal applications for National and MRP procedures to the IMB, MHRA and other regulatory authorities.
  • Provide responses to the competent authorities on deficiencies where they arise.
  • Review and update of summary of product characteristics and patient information leaflets as required.
  • Provide guidance and support regarding regulatory requirements as requested by clients.
  • Preparation of clinical trial submissions to various regulatory authorities.
  • Quality Control review of submission documentation prior to relevant competent authorities.
  • Perform internal audits & self-inspections to ISO 9000:2008 standard.
  • Participation in business development/marketing activities.

Skills / Experience

  • Degree minimum in a relevant area.
  • Significant experience in Regulatory setting (CRO / Medical Device / Pharma / Biotech).
  • Team player and client-focussed.