Principal Regulatory Affairs Associate jobs at Boston Scientific in Canada, Mississauga

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).

• Conducting detailed engineering assessments and designing fixturing systems for medical device manufacturing processes.
• Utilizing complex software tools (SolidWorks, Capture, PDM, and Windchill) to create technical designs that meet mechanical specifications for fixturing, tooling, and automation equipment.
• Using SolidWorks for design, including Simulation (FEA), to verify designs meet functional, structural, and performance requirements.
• Selecting appropriate materials for fixturing based on material properties, ensuring compatibility with medical device manufacturing processes.
• Applying structured problem-solving, lean principles, and best practice process development to enhance product and process efficiency.
• Designing and integrating mechanical and electro-mechanical systems, including components such as pneumatic actuators, grippers, motors, cameras/machine vision, and safety systems, to optimize fixturing for medical devices (strong controls knowledge).
• Leading and executing structured experimental plans to drive data-based decisions and validate designs.
• Performing critical engineering calculations such as speed, torque, load, stress, tolerance stack-up analysis, and force to ensure fixturing meets design requirements.
• Presenting technical data and design recommendations to key stakeholders in both formal and informal settings.
• Collaborating closely with SMEs and cross-functional teams to align fixturing solutions with manufacturing capabilities and medical device specifications.
• Providing mentorship and work direction to technicians and entry-level engineers on mechanical design and fixturing.
• Independently managing projects, meeting timelines, and documenting proof concepts with supporting data.
• Actively engaging in the design, fabrication, and assembly of fixturing, ensuring it meets functional requirements and integrates seamlessly with mechanical and electro-mechanical systems.
• Demonstrating strong communication skills to facilitate the design process and project completion.
• Ensuring compliance with the company’s Quality Management System, adhering to applicable standards, regulations, and procedures.
• Occasionally traveling as required to collaborate with teams, support equipment setup, and ensure design implementation.
• Performing other duties as needed to support team goals and business objectives.

• Bachelor’s degree in Mechanical Engineering.
• 9+ years of relevant mechanical design experience, particularly in designing fixturing, molding, and automation equipment for manufacturing processes.
• Proficiency in SolidWorks, with substantial experience in both design and simulation (FEA) for fixturing, tooling, and automation systems.
• Solid understanding of GD&T (Geometric Dimensioning and Tolerancing) and its application in mechanical design.
• Strong problem-solving skills and experience in root cause analysis to drive design improvements.
• Experience with experimental design, data analysis, and statistical methods to support engineering decisions.
• Excellent communication, organizational, and collaboration skills, with the ability to work independently and with a team.

• Work experience in the medical device industry, particularly with designing fixturing and tooling for medical device manufacturing.

Please note that if you are selected to advance in our recruitment process, you will be contacted to submit a design portfolio or CAD submission that showcases your mechanical design skills. This will help us assess your expertise and creativity in this field. Please ensure that your submission does not include any confidential or proprietary information from previous or current employers.

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).

About the role:

NOTE: This is a hybrid position, which requires work on-site in Mississauga at least (3) days per week.

Your responsibilities will include:

• Partnering with key stakeholders to understand priorities, outline assignments/schedules, and identify timelines to meet completion dates and R&D milestones.
• Develop direct reports and continue to evolve team structure and skillsets by recruiting, coaching and training high-performing staff.
• Monitor daily work operations and provide direction and guidance (technical and professional) to staff to achieve project goals.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organization objectives.
• Interact with all customers, by meeting regularly, responding to requests and providing project updates.
• Actively engage as part of the R&D Leadership team on Franchise initiatives and be a voice for the Labeling team.
• Engage in cross-functional, cross-site, and cross-team strategic discussions on how to drive results and efficiently execute activities.
• Monitors compliance with company policies and procedures (e.g. with FDA, BSI, EEO regulations, etc.).

Required qualifications:

• Bachelor’s degree in Engineering discipline
• 6+ years of relevant work experience
• Experience in people management and technical leadership
• Detailed understanding of design control process per ISO 13485 and 14971
• Ability to lead through change and adapt in a fast-paced environment

Preferred qualifications:

• Bachelor’s and/or Master’s in Mechanical, or Biomedical Engineering
• Strong interpersonal skills with ability to develop and maintain relationships
• Desire to grow and expand responsibilities as a functional manager

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).