Regulatory Affairs Specialist I

2 weeks ago

Toronto, Canada Boston Scientific Corporation Full time

**Work mode**:Hybrid**Onsite Location(s)**:Toronto, CA**Additional Locations**: Canada-ON-Mississauga**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**:
The Regulatory Affairs Specialist I (RASI) will be responsible for providing support to the Canadian Regulatory Affairs team for all Boston Scientific’s (BSC) divisions. This position plays an important role in maintaining compliance to the post-market surveillance requirements of products in Canada as required by the Medical Device Regulations and BSC procedures. Additional responsibilities will include but may not be limited to pre-market submission activities, process improvement projects as well as other assigned administrative tasks.- This is a 12-month contract (with a possibility of extension) and is eligible for hybrid work mode with the expectation of 1 day/week from our Brampton office.**Your responsibilities will include**:

- Ensures timely reporting of Medical Device Problem Reports (MDPRs) to Health Canada serving as the primary company contact
- Responsible for submitting recall reports to Health Canada
- Maintains compliance to Summary Report requirements across all BSC divisions
- Submit annual renewals for Medical Device Establishment License and Medical Device License Renewal
- Special Access program management including responsibility for inventory controls
- Track registration status of all products and documents and ensures systems and databases are updated accordingly
- Support regulatory requests from customer service, tenders, internal/external auditors and international groups
- Responsible for local approval of marketing promotional material
- Completion of other administrative tasks in support of regulatory team members as assigned
- Additional projects and/or responsibilities as required

**Required qualifications**:

- Bachelor's degree in Life Sciences
- Post-graduate certification in Regulatory Affairs
- Healthcare experience required; medical device preferred
- Knowledge and understanding of the Canadian Food and Drugs Act and Medical Devices Regulations
- Self-motivated and able to work productively with mínimal supervision
- Strong organizational and time management skills with the ability to multitask
- Commitment to contributing to a positive team environment
- Exceptional written and oral communication skills
- Strong computer skills in Microsoft Office - Word, Excel, PowerPoint

**Requisition ID**:579290- **Job Segment**:Regulatory Affairs, Medical Device, Compliance, Law, Business Process, Legal, Healthcare, Management

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