Regulatory Affairs Specialist, P2

Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. Review, assessment and sign-off on product and manufacturing changes in 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. Honours Bachelor's Degree (level 8) in life sciences, engineering or related field Basic knowledge of FDA and international regulations Ability to communicate complex ideas clearly and simply both orally and in writing Understanding of medical device regulations, FDA and international regulations. Team player with excellent interpersonal skills Demonstrated ability to effectively manage multiple projects and priorities General understanding of product development process and design control Ability to work independently with minimal supervision Submission drafting and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat