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Senior Regulatory Affairs Specialist at Boston Scientific Corporation Malaysia
Toronto, Ontario, Canada -
Full Time

Start Date

Immediate

Expiry Date

05 Jan, 26

Salary

0.0

Posted On

07 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Medical Devices, Project Management, Clinical Submissions, Research Skills, Analytical Skills, Problem-Solving Skills, Technical Writing, Communication Skills, Microsoft Word, Excel, Teams, PowerPoint, Adobe Acrobat, Fast-Paced Environment, Self-Motivated

Industry

Medical Equipment Manufacturing

Description
Bachelor's or master's degree in a scientific, technical, or related discipline. Postgraduate certification in a regulatory affairs program. 5+ years of regulatory affairs experience in the medical devices industry. Sound knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidance. Previous experience with high-risk medical device submissions. Demonstrated ability to effectively manage multiple projects and priorities. Basic computer skills, including experience with software applications such as Microsoft Word, Excel, Teams, and PowerPoint and Adobe Acrobat. Experience in managing clinical submissions. Effective research, analytical, and problem-solving skills. Excellent written and oral communication, technical writing, and editing skills. Ability to translate technical information into a clearly written message for regulators. Advanced computer skills to support submissions and communication or presentations both internally and externally (e.g., MS Word troubleshooting such as linkages/references, page numbers, section building, Table of Contents, etc.). Excellent writing skills, as demonstrated through submission writing experience. Quick learner, self-motivated, and independent worker with minimal supervision. Works well in fast-paced cross-functional team environments. Demonstrated ability to manage competing priorities effectively and execute on deliverables in fast-paced environment.
Responsibilities
The Senior Regulatory Affairs Specialist will manage regulatory submissions for high-risk medical devices and ensure compliance with Health Canada regulations. The role requires effective project management and the ability to communicate technical information clearly to regulators.