Job Description

About the role:
Boston Scientific is a place where you can easily find meaningful purpose through your life\'s work. We are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world for a wide range of medical conditions.

This 20-month contract position in Regulatory Affairs will support submissions and ongoing regulatory compliance for a Class III medical device used for treating patients with liver cancer. This is ideally a hybrid position (Ottawa, Canada) or remote for the right person.

Your responsibilities will include:

• Prepare, submit and manage regulatory submissions through to approval. Ensure product registrations are reviewed and renewed as required.
• Prepare, submit and support GMP applications; audit support
• Interact with regulatory agency personnel to expedite approval of submissions and answer any related questions.
• Act as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
• Perform regulatory assessments of product and manufacturing changes for compliance with applicable regulations.
• Establish and maintain a good working relationship with key cross-functional partners including regional Regulatory Affairs peers to gain positive and timely support for regulatory deliverables.
• Demonstrate a commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required qualifications:

• Minimum of a bachelor\'s degree
• Minimum of 5 years\' experience in Regulatory Affairs within the medical device industry
• Working knowledge of FDA, EU and/or international regulations for medical devices
• Prior submission experience including Design Dossier and Technical File reviews with Notified Bodies, PMA/510(k) submissions and/or international submissions

Preferred qualifications:

• Degree in a scientific, engineering or technical discipline
• Regulatory certification
• Regulatory experience with Class III medical devices
• General understanding of product development process and design control
• Proficiency with Microsoft Office and Adobe Acrobat; capable of working with various databases and document control/quality management software
• Effective written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision
• Ability to prioritize, plan and manage several projects
• Effective research and analytical skills

Requisition ID: 568452

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!

Boston Scientific