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.
- 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.
Check out all our open jobs on our HERO Recruitment website - www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval