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Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist
Contract Type: Permanent
Location: Galway
Industry:
REF: 90661
Job Published: 8 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

Senior Regulatory Affairs Specialist
Our client, a medical device company in Galway are currently looking to recruit a Senior Regulatory Affairs Specialist for their site.


Our Offer
  • You will be responsible for reviewing clinical protocols to be used in submissions.
  • Preparing, reviewing and filing appropriate FDA per market submission to ensure devices are commercially available in the U.S.: preIDEs, IDEs, 510(k)s, PMAs and PMA Supplements.
  • You will represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release.
  • You will support Design Control process. Prepare Rational to File documentation for modifications to devices when appropriate.
  • You will participate in FDA & other notified body Inspection.
  • You will communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.
  • You will develop and maintain Regulatory Strategies for new or modified products and prepare project plans & budgets. Monitor and provide management with impact of changes in the Regulatory environment.
Qualifications
Your Profile
  • We are looking for a qualified person to Bachelor's degree level in Engineering, scientific, or technical discipline.
  • 6+ years of Regulatory/Quality experience, 2+ years of medical device experience or relevant experience.
  • You are a dynamic team player and can work effectively and proactively on cross-functional teams.
  • You are experienced with U.S. and/or European/International regulations and standards; Experienced in preparing regulatory submissions; interacting with FDA and/or other regulatory agencies.
  • Provide a significant breadth of knowledge in Quality, project planning, technical expertise, and all areas of product development. Have knowledge of FDA regulations and TUV requirements.
  • You have a strong collaborative mindset to create alignment with cross functional players.
  • You are decisive with an ability to initiate and lead change.
  • You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 0868395533 / bimi@hero.ie
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