Regulatory Affairs Specialist

23 hours ago

Mississauga, Ontario, Canada Boston Scientific Full time
About the Role

The Regulatory Affairs Associate plays a vital role in supporting the Regulatory Affairs Manager with various regulatory activities, ensuring compliance with industry standards and regulations.

Key Responsibilities
  • Maintain accurate and up-to-date regulatory documentation and records.
  • Assist in preparing and compiling submissions and routine reports to regulatory authorities.
  • Respond to information requests from internal and external stakeholders, providing timely and accurate information.
  • Evaluate and advise on technical documents for submissions, ensuring compliance with regulatory requirements.
  • Assist with regulatory assessment of new products and changes made to existing products.
  • Contribute to the development of regulatory affairs strategy, aligning with company goals and objectives.
  • Review labeling and promotional materials to ensure compliance with regulatory requirements.
  • Ensure adherence to annual license renewals and registrations.
  • Adhere to and promote the adherence to all Corporate, Quality, and Health and Safety policies and procedures.
Requirements
  • Actively enrolled in a Life Sciences or related degree or a recent graduate from a Life Sciences or related degree.
  • Proficient in MS Office.
  • Exceptional communication, interpersonal, and organizational skills.
  • Proven work ethics and positive attitude.
  • Attention to accuracy, detail, and deadlines.
Preferred Qualifications
  • Pursuing a Post Graduate Certificate in Regulatory Affairs.
  • Excellent customer service skills.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Capable of working individually and/or in a team setting.
  • Ability to adapt and be flexible.

Boston Scientific is a leader in medical science, committed to solving the challenges that matter most. Our mission is to advance science for life, 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.

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