Regulatory Affairs Specialist Ii
9 hours ago
**Additional Locations**: Canada-ON-Toronto
**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 in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.
**About the role**
As a Regulatory Affairs Specialist II with Boston Scientific Canada, you will play a critical role in supporting the commercialization of innovative medical technologies that advance patient care. You will ensure timely and compliant regulatory approvals for our diverse product portfolio, working closely with Health Canada and other stakeholders to facilitate market access. By collaborating with cross-functional partners across the Commercial business, you will help enable the introduction of life-changing medical devices to the Canadian market.
**Your responsibilities will include**:
- Prioritize and plan product registration for responsible product lines.
- Maintain active knowledge of the status of pending approvals and registrations through the regulatory review process; provide management with regular updates on product registration.
- Establish a trusted relationship with Health Canada through regular meetings and discussions.
- Build and maintain strong collaboration with divisional RA peers to gain timely support for document preparation.
- Assist with regulatory assessment of new products and changes made to existing products.
- Provide input on regulatory-related issues associated with compliance and achieving the business plan.
- Support tender operations by timely supply of accurate regulatory documents.
- Review labeling and promotional material for compliance.
- Provide input and support the development of SOPs.
- Complete mandatory Quality training within the defined timeline and ensure compliance with internal Quality systems and policies.
**Required qualifications**:
- 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.
**Preferred qualifications**:
- 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.
- Previous Boston Scientific experience.
**Requisition ID**:615174
**Minimum Salary: $**66500**
**Maximum Salary: $**131800**
Compensation for **sales roles** is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).
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