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
• 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

Requisition ID: 609728

Minimum Salary: $95600 

Maximum Salary: $189800 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

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

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

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!