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Regulatory Affairs Specialist II at Boston Scientific Corporation Malaysia

Toronto, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, Project Management, Technical Writing, Communication Skills, Microsoft Word, Excel, Teams, PowerPoint, Adobe Acrobat, Class II Device Submissions, Class III Device Submissions, Health Canada Regulations, Self-Motivated, Fast-Paced Environment, Cross-Functional Teamwork

Industry

Medical Equipment Manufacturing

Description

Bachelor's or master's degree in a scientific, technical, or related discipline. 2+ years of regulatory affairs experience in the medical devices industry. Postgraduate certification in a regulatory affairs program. Working knowledge of the Canadian regulatory environment and Health Canada regulations, policies, and guidance. Previous experience with Class II or III device submissions. Demonstrated ability to effectively manage multiple projects and priorities. Basic computer skills, including Microsoft Word, Excel, Teams, PowerPoint, and Adobe Acrobat. Excellent written and oral communication, technical writing, and editing skills. Advanced computer skills to support submissions, communication, and presentations (e.g., MS Word troubleshooting such as references, section building, tables of contents). Quick learner, self-motivated, and independent worker with moderate supervision. Works well in fast-paced, cross-functional team environments.

Responsibilities

The Regulatory Affairs Specialist II will manage regulatory submissions and ensure compliance with Health Canada regulations. The role requires effective project management and collaboration within cross-functional teams.