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
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.
Primary Work Location
AUS Sydney - North Ryde
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.