Boston Scientific Senior Regulatory Affairs Associate 

Canada, Ontario, Mississauga 

473935275

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