Reg Affairs Specialist II

Join to apply for the Reg Affairs Specialist II (Contract) role at Boston Scientific. Additional Locations: Canada – ON – Ottawa Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you advance your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About The Role This 20‑month contract position within Regulatory Affairs will support regulatory submissions and ongoing compliance activities for a Class III medical device used in the treatment of liver cancer. This is a hybrid role based in Ottawa, Canada. Your Responsibilities Will Include Prepare, submit, and manage regulatory submissions through approval; ensure product registrations are reviewed and renewed as required. Prepare, submit, and support GMP applications. Support internal and external regulatory audits. Communicate with regulatory agency personnel to expedite submission approvals and address related inquiries. Serve as a core team member for product development teams, providing Regulatory Affairs guidance throughout the development lifecycle. Conduct regulatory assessments for product and manufacturing changes to ensure compliance with applicable regulations. Build and maintain strong working relationships with cross‑functional partners, including regional Regulatory Affairs colleagues, to secure timely support for regulatory deliverables. Demonstrate a commitment to patient safety and product quality by adhering to the Quality Policy and all documented quality processes and procedures. Required Qualifications Bachelor’s degree (minimum). At least 5 years of Regulatory Affairs experience within the medical device industry. Working knowledge of FDA, EU, and/or international medical device regulations. Hands‑on submission experience, such as Design Dossier and Technical File reviews, PMA/510(k) submissions, and/or international submissions. Preferred Qualifications Degree in a scientific, engineering, or technical discipline. Regulatory Affairs certification (e.g., RAC). Regulatory experience with Class III medical devices. General understanding of the product development process and design control practices. Proficiency with Microsoft Office and Adobe Acrobat; ability to work effectively with databases, document control systems, and quality management software. Strong written and verbal communication skills, including technical writing and editing. Ability to work independently with minimal supervision. Strong prioritization, planning, and project management skills. Effective research and analytical skills. Demonstrated ability to use AI tools to enhance efficiency, accuracy, and decision‑making (e.g., for regulatory research, document generation, data organization, or workflow optimization) and a willingness to integrate AI into everyday work processes. Requisition ID: 620669 Minimum Salary: $66,500 Maximum Salary: $131,800 We’re committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. We encourage you to apply and look forward to connecting with you Referrals increase your chances of interviewing at Boston Scientific by 2x. Seniority level: Not applicable. Employment type: Contract. #J-18808-Ljbffr