04 Nov
|
Johnson & Johnson
|
Sydney
04 Nov
Johnson & Johnson
Sydney
At Johnson & Johnson,we believe health is everything.
Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 setting 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: 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 to see how your unique talents will help patients on their journey to wellness.
The Opportunity As Assistant Manager, Regulatory Affairs ANZ, you'll lead regulatory activities across Australia and New Zealand, ensuring products meet all market legislation and directing post-marketing Lifecycle Management.
You'll mentor a team of regulatory professionals, sit on the ANZ Surgical Vision and Vision Care Leadership Teams, and act as a key regulatory expert, engaging agencies and trade associations to influence changing regulations.
Responsibilities
Direct growth, innovation and post-marketing Lifecycle Management activities, including claims, renewals, labelling and copy clearance
Lead regulatory strategies and submissions to health authorities, ensuring ongoing post-market compliance
Partner with regulators and trade associations to resolve issues and influence policy in line with business strategy
Anticipate emerging risks and drive best-practice regulatory policies, processes and SOPs
Develop the team, influence as a key leadership team member and manage the department budget
About You
Bachelor's degree in a scientific discipline (Master's preferred) with 6-8 years' related experience, ideally in medical devices Expert knowledge and practical application of regional government regulations Sound regulatory and business strategy expertise to gain and maintain the legal marketing status of a product portfolio Excellent organisational, communication and negotiation skills, with the ability to influence senior leaders, affiliates, regulators and industry Willingness to travel domestically and internationally (approx. 10%)
Why Choose Us:
Competitive remuneration package
Continuous training and support
Award-winning leadership development programs
Inclusive, flexible, and accessible working arrangements
Equal opportunity employer supporting diversity and inclusion
And much more...
Our Benefits:
Up to 18 weeks of parental leave to support current parents
4 days of volunteer leave to give back to the community
Option to purchase up to 2 weeks of additional annual leave for extra time off
Enjoy a dedicated Wellbeing Day to prioritise self-care
Global Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities
Access to an Employee Assistance Program for personal and professional support
Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support
Life insurance coverage for added peace of mind
And much more...
All applicants must have rights to work in Australia.
Required Skills: Preferred 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
At Johnson & Johnson,we believe health is everything.
Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 /.
Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive.
Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities.
If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.
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📌 Assistant Manager Reg Aff, Vision Anz (Sydney)
🏢 Johnson & Johnson
📍 Sydney