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.
- 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.
- 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.
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