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Regulatory Affairs Specialist
Our client, a medical device company in Tipperary is currently looking to recruit Regulatory Affairs Specialist for their site.
Regulatory Affairs Specialist is responsible for activities which lead to, and maintain regulatory approval to market devices. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications, and also ensures continued compliance with regulatory agency approvals.
- Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
- Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations
- Provides technical guidance and regulatory training/mentoring to cross-functional teams.
- Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
- Develops and implements regulatory strategies for new and modified products.
- Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
- Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.
- Ensures appropriate training is maintained to do the work and training is documented.
Qualifications/ and experience:
- Bachelor's Degree (level 8) in life sciences, engineering or related field
- U.S. and/or International medical device submissions experience
- 2 – 5+ years regulatory affairs experience or related experience in medical device industry
- Working knowledge of FDA and international regulations
- General understanding of product development process and design control
- Ability to communicate complex ideas clearly and simply both orally and in writing
- Demonstrated ability to effectively manage multiple projects and priorities
- Team player with excellent interpersonal skills
- Basic understanding of medical device regulations
- Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
- Ability to work independently with minimal supervision
- Previous experience with Class II and/or Class III medical devices submissions is desired
- Experience working directly with FDA, notified bodies and/or international health authorities is desired.
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