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Regulatory Affairs Specialist

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Mississauga, CA

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.

 

The Regulatory Affairs Specialist I (RASI) will be responsible for providing support to the Canadian Regulatory Affairs team for all Boston Scientific’s (BSC) divisions.  This position plays an important role in maintaining compliance to the post-market surveillance requirements of products in Canada as required by the Medical Device Regulations and BSC procedures.  Additional responsibilities will include but may not be limited to pre-market submission activities, process improvement projects as well as other assigned administrative tasks.   This role is eligible for hybrid work mode with the expectation of 1 day/week from our Brampton office.

This position reports to the Senior Manager, Regulatory Affairs.

 

Responsibilities:

  • Ensures timely reporting of Medical Device Problem Reports (MDPRs) to Health Canada serving as the primary company contact
  • Responsible for submitting recall reports to Health Canada
  • Maintains compliance to Summary Report requirements across all BSC divisions
  • Submit annual renewals for Medical Device Establishment Licence and Medical Device Licence Renewal
  • Special Access program management including responsibility for inventory controls
  • Compile regulatory submissions including class II applications, fax-back amendments, quality management system certificate updates, responses to agency questions and other HC correspondence
  • Track registration status of all products and documents and ensures systems and databases are updated accordingly
  • Support regulatory requests from customer service, tenders, internal/external auditors and international groups
  • Responsible for local approval of marketing promotional material
  • Completion of other administrative tasks in support of regulatory team members as assigned
  • Additional projects and/or responsibilities as required

 

Required Education and Experience:

  • Bachelor's degree in Life Sciences
  • Post-graduate certification in Regulatory Affairs would be an asset
  • Healthcare experience required; medical device preferred
  • Knowledge and understanding of the Canadian Food and Drugs Act and Medical Devices Regulations
  • Self-motivated and able to work productively with minimal supervision
  • Strong organizational and time management skills with the ability to multitask
  • Commitment to contributing to a positive team environment
  • Exceptional written and oral communication skills
  • Strong computer skills in Microsoft Office - Word, Excel, PowerPoint       

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 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!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

 

AODA

Boston Scientific Ltd. is required to and will comply with certain provisions contained in the Accessibility for Ontarians with Disabilities Act, 2005 (AODA) and Part III-Employment Standards of the Integrated Accessibility Standards Regulation made under the AODA.  BSL is committed to accommodation as required.

 


Job Segment: Regulatory Affairs, Medical Device, Compliance, Law, Program Manager, Legal, Healthcare, Management

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