Principal Regulatory Affairs Associate

**Additional Locations**: Canada-ON-Mississauga; 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 this role**:
The Principal Regulatory Specialist will support regulatory activities for the Access Solutions Franchise within the Electrophysiology division. In this role, you will develop and implement regulatory strategies to support product development, approvals, and ongoing regulatory compliance. You will collaborate closely with cross functional teams to influence and drive decisions that align with business objectives and regulatory requirements. The position requires strong leadership, communication and strategic thinking to ensure regulatory success in a dynamic and fast paced environment.

At Boston Scientific, we value collaboration and synergy. This position follows a hybrid work model, requiring employees to be onsite at a local Boston Scientific office at least three days per week.

Please note that relocation assistance is not available for this role at this time.

Additionally, Boston Scientific does not offer sponsorship or assume sponsorship of employment visas for this position

**Your responsibilities will include**:

- Develops and implements regulatory strategies for new and modified products
- Acts as a core member on new product development and sustaining teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions
- Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
- Provides guidance to other team members during strategy formulation, submission preparation and interaction with regulatory bodies
- Supports efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
- Supports external audits and maintain audit readiness

**Required Qualifications**:

- Minimum of a Bachelor's Degree in a scientific or technical discipline
- Minimum of 7 years of experience in the medical device industry, or 5 years’ experience with an advanced degree (Master’s or PhD)
- Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards
- Demonstrated experience authoring/supporting a variety of regulatory submissions
- Demonstrated ability to effectively lead multiple regulatory projects and priorities
- Excellent written and oral communication, technical writing, and editing skills
- Ability to articulate complex ideas clearly both verbally and in writing
- Ability to work independently with mínimal supervision, as well as mentor/guide others

**Preferred Qualifications**:

- Demonstrated leadership, strategic thinking, project planning, and project management skills
- Understanding of product development process and design controls
- Familiarity with international regulatory requirements
- Excellent organizational, communication and collaboration skills. Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources

**Requisition ID**:609728

**Minimum Salary: $**95600**

**Maximum Salary: $**189800**

Compensation for **sales roles** is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).