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Reg Affairs Specialist II (Contract) at Boston Scientific Corporation Malaysia
Ottawa, Ontario, Canada -
Full Time

Start Date

Immediate

Expiry Date

17 Mar, 26

Salary

0.0

Posted On

17 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Medical Device Regulations, Submission Experience, Technical Writing, Project Management, Analytical Skills, AI Tools, Microsoft Office, Adobe Acrobat, Design Control Practices, Communication Skills, Database Management, Quality Management Software, Research Skills, Class III Medical Devices, Regulatory Certification, Product Development Process

Industry

Medical Equipment Manufacturing

Description
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. 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.
Responsibilities
The Regulatory Affairs Specialist II will be responsible for ensuring compliance with FDA, EU, and international medical device regulations. This includes hands-on submission experience and collaboration throughout the product development process.