Special Projects Regulatory Affairs Lead, Anz

**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
Professional
**All Job Posting Locations**:
North Ryde, New South Wales, Australia

**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.

**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**
- Degree and/or post-graduate qualification in Regulatory Affairs, Engineering, Science or related discipline, with minimum 8 years Regulatory Affairs specialist industry experience, with at least 2-3 years in a lead capacity within the medical device industry
- Previous experience managing, or leading projects, with highly developed engagement, negotiation, influencing, and leadership skills
- Experience with regulatory submissions, change and risk management processes, along with strong attention to detail
- Commercial acumen, who is results and solutions focussed, along with excellent communication, prioritisation and time management skills
- Ability to work well under pressure to meet deadlines and to make sound decisions daily concerning regulatory affairs

**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

**Our Benefits**:

- Up to 18 weeks of parental leave to support new 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...

**Great Place to Work Certified - 2024**

Great Place to Work Certification recognises employers who create outstanding employee experience. The certification process is recognised worldwide as the global benchmark for identifying outstanding workplaces.

Johnson & Johnson - Australia and New Zealand were certified as a Great Place to Work in ANZ in its first year of participation.
- All applicants MUST have rights to work in Australia._