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About the Role

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.

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.

Requirements

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).
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 tracking tools.
Strong organizational, communication, and stakeholder management skills.
Project management certification (e.g., PMP, PRINCE2) or equivalent experience.
Advanced degree or formal training in Regulatory Affairs or Project Management.
Fluent English (written and verbal).
Limited domestic and occasional international travel.
Regulatory Affairs Certification (RAC) preferred but not required.
Candidates without dedicated change management background are not being considered for this role.

Skills

Analytical Reasoning
Business Writing
Coaching
Collaboration
Communication
Legal Support
Problem Solving
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Regulatory Reporting
Risk Assessments
Strategic Thinking

Location

North Ryde, New South Wales, Australia
Mount Wellington, Auckland, New Zealand

Work Type

Hybrid

Experience Level

5+ years

Education Level

Bachelor’s degree in a scientific, engineering, or health‑related discipline
Advanced degree or formal training in Regulatory Affairs or Project Management

Benefits

Competitive remuneration package
Continuous training and support
Award-winning leadership development programs
Inclusive, flexible, and accessible working arrangements

About the Company

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.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Equal Opportunity

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.