Senior Regulatory Affairs Specialist

Additional Locations: 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 the role

As a Senior Regulatory Affairs Associate with Boston Scientific, you will play a pivotal role in enabling timely access to these technologies by ensuring regulatory compliance and facilitating approvals with Health Canada. Working within a fast-paced, collaborative environment, you will help shape regulatory strategy, expedite product registrations, mentor junior associates, and contribute to process improvements, all while supporting the successful introduction of life-changing therapies in Canada.

Your responsibilities will include:

• Prioritize and plan product registration for responsible product lines.
• Preparing, coordinating and submitting regulatory applications to Health Canada.
• Maintain an active knowledge of the status of pending approvals and expedite registrations through the regulatory review process. Provide the management team with regular updates on product registration.
• Develop and communicate regulatory affairs strategy for new product introduction and other projects.
• Establish and maintain a good working relationship with divisional RA peers to gain positive & timely support for document preparation.
• Assist with regulatory assessment of new products and changes made to the product.
• Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
• Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
• Provides input on regulatory-related issues associated with compliance and achieving the business plan.
• Establish relationships with local medical device industry groups and work with industry peers to lobby in matters of regulatory issues and to influence local policies.
• Supports tender operations by timely supply of accurate regulatory documents.
• Serves as regulatory expert to internal and external customers.
• Labeling and promotional material review.
• Development of SOPs in alignment with corporate and local regulations.
• Adhere to and promote the adherence to all Corporate and Quality policies and procedures.

Required qualifications:

• Bachelor's or master's degree in a scientific, technical, or related discipline.

• Postgraduate certification in a regulatory affairs program.

• 5+ years of regulatory affairs experience in the medical devices industry.
• Sound knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidance.
• Previous experience with high-risk medical device submissions.
• Demonstrated ability to effectively manage multiple projects and priorities.
• Basic computer skills, including experience with software applications such as Microsoft Word, Excel, Teams, and PowerPoint and Adobe Acrobat.

Preferred qualifications:

• Experience in managing clinical submissions.
• Effective research, analytical, and problem-solving skills.
• Excellent written and oral communication, technical writing, and editing skills. Ability to translate technical information into a clearly written message for regulators.
• Advanced computer skills to support submissions and communication or presentations both internally and externally (e.g., MS Word troubleshooting such as linkages/references, page numbers, section building, Table of Contents, etc.).
• Excellent writing skills, as demonstrated through submission writing experience.
• Quick learner, self-motivated, and independent worker with minimal supervision.
• Works well in fast-paced cross-functional team environments.
• Demonstrated ability to manage competing priorities effectively and execute on deliverables in fast-paced environment.

Requisition ID: 615175

Minimum Salary: $79700

Maximum Salary: $158200

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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