Regulatory Affairs Specialist Ii

2 weeks ago

Toronto, Canada Boston Scientific Corporation Full time

**Regulatory Affairs Specialist II**:

- Remote Eligible: Hybrid- Onsite Location(s): Toronto, CA**Purpose and Passion - Comprehensive Benefits - Life-Work Integration - Community - Career Growth**

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work. Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations’ preparation and documentation. Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team with regular updates on product registration and new regulations from government body.

**Requirements**:

- 1-4 years regulatory affairs experience in the medical devices industry
- Postgraduate certification in a regulatory affairs program
- Bachelor’s degree in life sciences, engineering, or related discipline (Advanced degree is an asset)
- Strong knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidance
- Previous experience with Class III or IV device submissions
- Demonstrated ability to effectively manage multiple projects and priorities

**Responsibilities**:

- Provides input on regulatory-related issues associated with compliance and achieving the business plan.
- Prioritize and plan on product registration for his/her respective product lines.
- Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. Provide the management team with regular updates on product registration.
- Ensure product registrations are reviewed and renewed as required.
- Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
- Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
- Supports tender operations by timely supply of accurate regulatory documents.
- Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
- Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
- Serves as regulatory consultant to marketing team and government regulatory agencies.

**AODA**

Boston Scientific Ltd. is required to and will comply with certain provisions contained in the _Accessibility for Ontarians with Disabilities Act. 2005 _(AODA) and Part III-Employment Standards of the Integrated Accessibility Standards Regulation made under the AODA. BSL is committed to accommodation as required.

**Req ID 558584**:
**Job Segment**:Regulatory Affairs, Compliance, Medical Device, Law, Engineer, Legal, Healthcare, Engineering

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