Special Projects Regulatory Affairs Lead, ANZ

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
North Ryde, New South Wales, Australia

Job Description:

About MedTech

Fuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalised treatments.

Visit us at https://www.jnj.com/medtech to see how your unique talents will help patients on their journey to wellness.

The Opportunity

Working closely with the APAC RA Regional Lead, and Global PMOs, the Regulatory Affairs Lead will head up the Special Projects team in ANZ and drive the execution of RA initiatives for our medical device business units.

Leading by example to the team, you will work collaboratively and partner with key stakeholders and business unit leaders within the organisation and play a pivotal part in ensuring regulatory excellence and compliance for Johnson & Johnson’s suite of cutting-edge medical devices.

Responsibilities


* Leading and developing regulatory strategies for all Special Projects, aligning with internal partners across the organisation (including global PMOs, local RA, Supply Chain, Marketing and Quality etc.), ensuring stakeholders' voices are evaluated within strategies


* Providing prioritisation, capacity management, and efficiency gain options for Special Project Programs in ANZ


* Working collaboratively with country or local franchise RA leaders, leading executions of all Special Projects, and setting up project plans with detailed tasks and timelines to avoid registration misses


* Being accountable for completing Special Project impact assessments, and all RA actions accurately, and ensuring timely MDRiM updates for each RA action, SEP dates, license updates and code linkage to country licenses as per SOPs


* Being part of the APAC RA leadership team and representing ANZ; sharing best practices on Special Project executions, and responsible for achieving and maintaining appropriate metrics for ANZ Programs as per 2025 G&Os


* Adhering to all policies and legislations, and maintaining the highest levels of professionalism, ethics and compliance always


* Recruiting and hiring RA resources as needed, diligently participating in compliance program-related activities, and effectively leading, coaching, and developing a high performing, collaborative team

About You


* D...