Regulatory Affairs Manager in Sydney

Regulatory Affairs Manager in Sydney

Sydney Full-Time 49500 - 60500 $ / year (est.) Hybrid
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At a Glance

  • Tasks: Lead regulatory compliance for innovative eyewear and medical devices across ANZ.
  • Company: Join EssilorLuxottica, a global leader in eyewear and vision solutions.
  • Benefits: Generous product allowance, discounts, wellness amenities, and hybrid work options.
  • Other info: Exciting career growth opportunities in a dynamic and supportive environment.
  • Why this job: Make a real impact on vision care while working with iconic brands.
  • Qualifications: 8+ years in Regulatory Affairs with strong stakeholder management skills.

The predicted salary is between 49500 - 60500 $ per year.

We are Essilor Luxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses.

We bring together the expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, creating a vertically integrated business that is uniquely positioned to address the world’s evolving vision needs.

We craft exclusive eyewear brands Ray-Ban, Oakley, Oliver Peoples, Persol, Costa and more, alongside esteemed licensed brands such as Tiffany & Co, Burberry, and CHANEL whilst our cutting-edge lenses Varilux and Transitions lead the industry in innovation.

In Australia and New Zealand, we operate the iconic retail and eye care brands: Sunglass Hut, Oakley, OPSM, Ray-Ban and Laubman & Pank .

Every day, Essilor Luxottica’s 190,000 employees in 150 countries work towards a common mission to help people see more and be more.

Lead Regulatory Affairs for Essilor Luxottica’s Professional Solutions business in ANZ.

This senior role offers regional ownership of regulatory strategy and execution across a diverse portfolio of medical devices, ophthalmic equipment, lenses and emerging technologies.

Partnering with global and local stakeholders, you’ll drive regulatory excellence, ensure product compliance and provide expert guidance to support business objectives while maintaining the highest standards of safety and quality.

Key Responsibilities

  • Lead regulatory compliance across the ANZ medical device portfolio
  • Manage product registrations, ARTG and Medsafe listings.
  • Oversee post-market surveillance, adverse event reporting and product recalls.
  • Ensure product labelling, marketing materials and advertising claims meet regulatory requirements.
  • Partner with global and local teams to embed compliance into business processes.
  • Act as the key liaison with regulatory authorities across Australia and New Zealand.
  • Monitor regulatory changes, assess risks and drive continuous improvement.
  • Provide expert regulatory advice to senior leaders and cross-functional stakeholders.

About You

  • Bachelor’s degree in Life Sciences, Engineering, Pharmacy or a related field.
  • 8+ years’ Regulatory Affairs experience within medical devices or pharmaceuticals.
  • Strong knowledge of Australian and New Zealand regulatory frameworks
  • Proven experience managing submissions, registrations and compliance programs.
  • Strong stakeholder management skills, with the ability to influence and advise at a senior level.
  • Excellent analytical, problem-solving and decision-making skills.
  • A proactive, risk-aware approach with a focus on continuous improvement.
  • Strong project management skills and the ability to manage competing priorities.
  • Postgraduate qualifications or a Regulatory Affairs certification (RAPS or equivalent) will be highly regarded.
  • Working at Essilor Luxottica

A career with Essilor Luxottica will offer you rewarding experiences and the opportunity to develop your skills every day.

Working at our head-office located in North Sydney, you will enjoy

  • Generous yearly $1,500 product allowance and Family & Friends discounts of up to 50% off to splurge across all our brands – OPSM, Sunglass Hut, Oakley, Ray-Ban, Laubman & Pank and Eye Q
  • Up to 50% off Oakley eyewear and apparel throughout the year.
  • Wellness amenities including reformer a Pilates studio, Yoga classes, Personal training and Bike storage.
  • Abundance of local cafes, a major shopping centre and close to public transport facilities
  • Volunteering with our charity partner One Sight, including volunteer leave and i Champion ambassador opportunities.
  • Wide range of career opportunities across the Essilor Luxottica network
  • Complimentary full-time concierge services offering an exclusive hotel-style experience!
  • Options for a hybrid working environment

Competitive remuneration, commensurate with experience and capability.

*Please note, due to the high volume of applications only successful candidates will be contacted. We thank you in advance for your interest in Essilor Luxottica*

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Regulatory Affairs Manager in Sydney employer: EssilorLuxottica

EssilorLuxottica is an exceptional employer that prioritises employee growth and well-being, offering a dynamic work culture in Silverwater. With generous benefits like a yearly product allowance, significant discounts on eyewear, and global volunteering opportunities, employees are empowered to thrive both personally and professionally. The company fosters an inclusive environment where team members feel valued and supported, making it a rewarding place to build a meaningful career in quality assurance.

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Contact Details:

EssilorLuxottica Recruitment Team

We think you need these skills to ace Regulatory Affairs Manager in Sydney

Regulatory Compliance
Product Registration
ARTG and Medsafe Listings
Post-Market Surveillance
Adverse Event Reporting
Product Recalls
Stakeholder Management