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RA Project Manager, ANZ

Johnson & Johnson

North Ryde New South Wales AustraliaSeniorH-1B sponsor company
Sign in to applyVerified 1h ago
Location
North Ryde New South Wales Australia
Work model
On-Site
Level
Senior
H-1B history
2 approvals (FY2023)
Posted
11h ago

About this role

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Mount Wellington, Auckland, New Zealand, North Ryde, New South Wales, Australia Job Description: DePuy Synthes is recruiting for a RA Project Manager, ANZ, located in North Ryde, New South Wales, Australia. Join our change journey at J&J—help shape what’s next   Step into a high-impact career opportunity with real visibility     THE OPPORTUNITY   The RA Project Manager, ANZ plays a critical role in enabling timely patient access to DePuy Synthes orthopedic solutions by leading regulatory strategy and coordinating regulatory activities across Australia and New Zealand. This role partners closely with global, regional, and local stakeholders to plan, execute, and track regulatory submissions and lifecycle activities, ensuring compliance with ANZ regulatory requirements while supporting business growth and innovation. This is an exciting opportunity to operate at the intersection of regulatory strategy, project leadership, and cross‑functional collaboration, with visible impact on product availability, market expansion, and operational excellence across the ANZ region.

Responsibilities

Lead and manage regulatory project plans for new product introductions, renewals, and lifecycle changes across Australia and New Zealand. Coordinate cross‑functional regulatory activities with local, regional, and global partners (RA, R&D, Clinical, Medical, Quality, Supply Chain, Marketing). Develop and maintain detailed regulatory timelines, risk assessments, and status reporting to ensure on‑time delivery. Prepare, compile, and support regulatory submissions and responses to health authority questions in accordance with TGA and Medsafe requirements. Serve as the primary regulatory project contact for assigned ANZ initiatives, proactively identifying risks and mitigation strategies. Ensure alignment of local regulatory execution with global regulatory strategies and company objectives. Track and manage regulatory commitments, post‑market changes, and license maintenance activities. Support continuous improvement of regulatory project management processes, tools, and metrics within QARA International. Mentoring and technical support to Regulatory Affairs associates  as required ABOUT YOU   REQUIRED 5+ years of experience in Regulatory Affairs, Regulatory Operations, or Regulatory Project Management within medical devices, pharmaceuticals, or combination products. Demonstrated experience managing regulatory timelines and cross‑functional deliverables. Working knowledge of ANZ regulatory frameworks (TGA and Medsafe). Ability to manage multiple projects simultaneously in a matrixed, global environment. Bachelor’s degree in a scientific, engineering, or health‑related discipline (e.g., Biomedical Engineering, Life Sciences, Pharmacy). DESIREABLE Experience supporting orthopedic or medical technology product portfolios. Familiarity with global regulatory submission processes and change management. Experience using regulatory information management systems (RIMS) or project

RA Project Manager, ANZ at Johnson & Johnson — North Ryde New South Wales Australia | Yoinka