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BD (Becton, Dickinson and Company) Senior Regulatory Affairs Associate in Mississauga, Canada

Job Description Summary

This results-driven individual will provide regulatory support to BD operations for market entry and maintenance of BD products including medical devices, drugs and natural health products.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Classification and preparation of regulatory submissions, and effective negotiation of approvals for device and drug applications to Health Canada

  • Perform regulatory activities such as new product activation, assessment of post-market changes, and copy approval of labeling and promotional material

  • Provide guidance and interpretation of regulatory requirements to project teams, Business Leaders and other associates as needed

  • Assist in the management of regulatory compliance activities including coordination of product recalls and support during audits and inspections

  • Assist in the management of regulatory activities involving compliance to government regulations and maintenance of product licenses, establishment licenses, and quality management system certificates

  • Actively participate on regional and cross-functional teams

  • Represent BD on external committees (e.g. MEDEC sub-committees) as required

QUALIFICATIONS

  • Excellent verbal and written communication skills

  • Flexible and adaptable to fulfill business priorities

  • Lead projects with minimal direction and under tight deadlines

  • Organization and time management skills to handle multiple activities

  • Ability to actively participate in a team environment

  • Strong analytical, problem solving and decision making skills

EDUCATION AND EXPERIENCE

  • Bachelor of Science degree in life sciences

  • 4-5 years regulatory affairs experience in the medical device industry, pharmaceutical experience is an asset

  • Working knowledge of Canadian regulations for medical devices and drugs

  • Solid experience in preparation of Class II, III and IV Medical Device and IVDD applications

Primary Work Location

CAN Mississauga - Derry Road West

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

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