Regulatory Affairs Specialist II

Additional Locations:Canada-ON-Toronto

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role

As a Regulatory Affairs Specialist II with Boston Scientific Canada you will play a critical role in supporting the commercialization of innovative medical technologies that advance patient care. You will ensure timely and compliant regulatory approvals for our diverse product portfolio working closely with Health Canada and other stakeholders to facilitate market access. By collaborating with cross-functional partners across the Commercial business you will help enable the introduction of life-changing medical devices to the Canadian market.

Your responsibilities will include:

• Prioritize and plan product registration for responsible product lines.
• Prepare coordinate and submit regulatory applications to Health Canada.
• Maintain active knowledge of the status of pending approvals and registrations through the regulatory review process; provide management with regular updates on product registration.
• Establish a trusted relationship with Health Canada through regular meetings and discussions.
• Build and maintain strong collaboration with divisional RA peers to gain timely support for document preparation.
• Assist with regulatory assessment of new products and changes made to existing products.
• Provide input on regulatory-related issues associated with compliance and achieving the business plan.
• Support tender operations by timely supply of accurate regulatory documents.
• Review labeling and promotional material for compliance.
• Provide input and support the development of SOPs.
• Complete mandatory Quality training within the defined timeline and ensure compliance with internal Quality systems and policies.

Required qualifications:

• Bachelors or masters degree in a scientific technical or related discipline.
• 2 years of regulatory affairs experience in the medical devices industry.
• Postgraduate certification in a regulatory affairs program.
• Working knowledge of the Canadian regulatory environment and Health Canada regulations policies and guidance.
• Previous experience with Class II or III device submissions.
• Demonstrated ability to effectively manage multiple projects and priorities.
• Basic computer skills including Microsoft Word Excel Teams PowerPoint and Adobe Acrobat.

Preferred qualifications:

• Excellent written and oral communication technical writing and editing skills.
• Advanced computer skills to support submissions communication and presentations (e.g. MS Word troubleshooting such as references section building tables of contents).
• Quick learner self-motivated and independent worker with moderate supervision.
• Works well in fast-paced cross-functional team environments.
• Previous Boston Scientific experience.

Requisition ID:615174

Minimum Salary: $66500

Maximum Salary: $131800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --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) isnt just business its personal. And if youre 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!