Boston Scientific Principal Regulatory Affairs Associate 

Canada, Ontario, Mississauga 

822188934

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.

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
• Prepares and submits regulatory applications, as well as internal regulatory file documentation
• 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 international regulatory partners with commercial marketing applications
• 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 minimal 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

Compensation forhourly, non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for
salaried, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation foris governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).