Connecting...

Principal Regulatory Affairs

Client Details

Leader in medical devices and patient technology.

Description

You will be part of a high performing regulatory team, responsible for defining and executing regulatory strategies for the assigned business units in alignment with ANZ strategic plan. You will be exposed to products across all classes up to Class III and conformity assessment. You will regularly liaise with local and overseas suppliers and manufacturers to facilitate timely product registrations for new technologies and the ongoing management of existing licences.
  • Acts as a regulatory representative to influence, negotiate and support successful product submissions with regulatory bodies, including regulatory strategy, submission preparation, commercialization of product and labelling compliance
  • Acts as a company sponsor to cross functional and cross divisional leaders to communicate and provide understanding of regulatory requirements
  • Keep up to date with regulation changes and advise management of potential impact to the business
  • Manage changes to existing products to ensure continued compliance to regulations
  • Support the review and approval of promotional and advertising materials to ensure compliance with the regulations
  • Provide post-market support as required
  • Lead projects using knowledge and application of regulations and standards related to medical device regulatory affairs, i.e. integration of acquired businesses (as required)
Profile
  • Absolute expertise regards regulatory affairs and product registrations gained from within a medical device business and pharmaceutical 
  • Experience in managing complex regulatory submissions across all device classifications, primarily Class III and conformity assessment
  • Established relationships and experience in dealing with various divisions within the TGA
  • Demonstrated experience in leading projects
  • Understanding of EU MDR, implications for Australian regulatory environment
  • Ability to influence unique and creative solutions to meet customer needs
  • A Tertiary qualified expert in stakeholder management and engagement with the ability to challenge the status quo and corporate thinking
  • A highly flexible and adaptable approach to management resources and an engaging, empathetic style of leadership with a passion for team development and product delivery
  • A passion for product and patient delivery and a real desire to improve the lives of people through your work

Job Offer
  • Attractive salary and annual bonus
  • Design and deliver strategies that place customers at the centre of business decisions
  • Work with diverse and high-performance colleagues, tackling some of the most important health industry challenges
  • Be part of an enriching culture born on values, purpose, imagination and spirit
  • Flexible working environment and fantastic staff benefits
 
This is more than just another job. This is a place where you can find meaningful purpose, improving lives through your work.
 
Click the 'Apply Now' button ASAP! If you have any questions or would like to have a confidential discussion, please call Corin Roberts in our Sydney office on (02) 9195 2929