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BD (Becton, Dickinson and Company) Regulatory Affairs Business Partner in Sydney, Australia

Job Description Summary

  • Regulatory submissions for Class I-III products

  • Full TGA Conformity Assessments

  • Supporting Notified Body Audits

  • Management of the new product launch process & notification of change process

  • Legal Manufacturer Activities - Oversight of New Product Development process

  • Approval of advertising & promotional material

Job Description

Responsibilities :

  • Organisation, planning and preparation of TGA submissions for new products, and Medsafe WAND Notifications - in conjunction with marketing launch plans.

  • Maintenance and update of regulatory status of existing medical device products on the Australian Register of Therapeutic Goods.

  • Oversight of New Product Development, Product Change and New Component Qualification processes, in conjunction with the Malaysian manufacturing facility

  • Updating technical documentation such as Clinical Evidence Report, Risk Documentation, ERC for the Lifemed Products

  • Provide support to manager on regulatory matters when necessary.

  • Provide regulatory information to sales and marketing personnel and external customers.

  • Maintenance of product registration database

  • Review & approval of advertising and promotional material

Skills and Experience:

  • Knowledge of relevant Legislation such as the Therapeutic Goods Act and Regulations.

  • Ability to communicate with TGA and Medsafe staff when required on regulatory matters.

  • Ability to communicate with overseas manufacturers and the Bard Divisions.

  • Ability to communicate with marketing and other departments within the company.

  • Attention to detail and organisational skills.

  • Needs to be flexible at times re work hours due to need for calls in morning

  • Proactive – takes initiative.

  • Well organised/good at following up.

  • Builds strong relationships.

  • Strong and not frightened to push and chase for info when required.

  • Team player.

Primary Work Location

AUS Sydney - North Ryde

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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