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Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist
Contract Type: Permanent
Location: Galway
Industry:
REF: 89939
Job Published: about 1 year 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.
  • Leadership Expectations provide the framework for what we expect from all employees at the company - outlining the actions and behaviours we must develop and demonstrate in pursuit of our Mission and global growth goals.
For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 0868395533 / bimi@hero.ie
Check out all our open jobs on our HERO Recruitment website - www.hero.ie
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