Senior Regulatory Affairs Associate

3 weeks ago

Mississauga, Canada Boston Scientific Full time
Additional Locations: Canada-ON-Mississauga

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.

Please note this is a 1-year contract opportunity.

About the role

The Regulatory Affairs Senior Associate supports the Manager, Regulatory Affairs in ensuring rapid and timely approvals for respective product lines. This involves planning for all product registration and managing all product registrations’ preparation and documentation. Furthermore, they will interact with regulatory agency personnel to expedite approval of pending registration as well as answer any questions on product documentation.

Your responsibilities will include:

-Plan, organize, assemble and file medical device license applications and regulatory dossiers to Health Canada, FDA and EU Notified Body
-Develop and communicate regulatory affairs strategy for new product introduction and other projects
-Assist with regulatory assessment of new products and changes made to the product
-Review of design history file documents and advise R&D team on regulatory requirements
-Labeling and promotional material review
-Development of SOPs
-Liaise and develop positive relationships with internal and external customers
-Stay abreast of regulatory changes
-Adhere to and promote the adherence to all Corporate, Quality and Health and Safety policies and procedures
-Other duties as required
 

Required qualifications:

-4+ years of relevant experience in the medical device industry
-Sound knowledge of Canadian, US, and EU regulations and guidelines for medical devices
-Sound knowledge of medical device development process and design control requirements, including risk management
 

Preferred Qualifications:

-Master’s degree in Life Science or related field
-Post Graduate Certificate in Regulatory Affairs
-Ability to adapt and be flexible, positive attitude and excellent interpersonal skills
-High level of attention to detail and accuracy
-Excellent writing skills, as demonstrated through submission writing experience
-Exceptional communication and organizational skills
-Capable of collaborating with cross-functional teams
-Demonstrated ability to manage competing priorities effectively and execute on deliverables in fast-paced environment
 

Requisition ID: 580626

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 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 and look forward to connecting with you
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