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Regulatory Specialist

2 weeks ago

Sydney, Australia 2San Full time

**COMPANY OVERVIEW**

**We believe in **Excellence**, **Integrity**, **Agility**, **Rigor **and **Fearlessness**. To consistently deliver on our promise of “**Better care. Better life**”, these five core values form the bedrock of our identity, culture and success. They give us a common purpose and we all collectively understand them, work towards them and live by them every day.**

2San is a leading global distributor designing and delivering an expanding range of products and solutions that fit into three core categories: Clean, Protect and Test.

We’ve grown rapidly into an industry ‘disruptor’ in our own right by championing innovative products and solutions that seek to deliver better care, better life. We advocate for the movement that empowers people to own their own health and make informed decisions about it.

As a partner of choice, 2San’s client-base has spans government institutions worldwide, at central and region/state levels, the private healthcare sector, and some of the largest private sector corporations on the global stage: MacDonald’s, Costco, Amazon, Walmart, Rolls Royce and the Woolworths Group, to name but a few.

We have ambitious plans for our future and as a valued member of our team we look to you to share in, and embody, our vision - to make our journey your journey. We’re invested in you, and dedicated to fostering a vibrant culture that develops your skills, nurtures your potential, and stimulates your professional growth for a lasting career with us.

This job profile will not remain static as you will be empowered to map out your own trajectory and showcase your abilities to ensure you reach potential and thrive.

**ROLE OVERVIEW**

At 2San, we are at the forefront of innovation in the global healthcare industry, dedicated to improving lives with our principle of “Better care. Better life”. Our team in Australia plays a pivotal role in this mission, focusing on the distribution and regulatory management of Class 2 and Class 3 Self-Test In Vitro Diagnostic devices (IVDs). As we continue to grow and disrupt the industry with our innovative products and solutions, we are looking for a Regulatory Specialist to join our dynamic team.

**KEY ACCOUNTABILITIES/RESPONSIBILITIES**
- Monitoring and management of new and existing ARTG entries to ensure all product listings are current and compliant with Australian regulatory requirements.
- Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements.
- Maintaining regular contact with manufacturers for products sponsored in Australia. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR).
- Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both Australian and international standards, including ISO 13485, and addressing any gaps or non-compliances.
- Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements.
- Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management.
- Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches.
- Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions.
- Engaging in regular communication with regulatory bodies, including the TGA, to facilitate product approvals, respond to queries, and maintain a positive working relationship.
- Coordinating with internal teams and external partners to ensure consistent and effective regulatory practices across all aspects of the business.
- Managing multiple projects and regulatory initiatives simultaneously, prioritizing tasks to meet deadlines without compromising quality or regulatory compliance.
- Keeping abreast of regulatory changes, trends, and best practices within the healthcare and IVD sector and disseminating relevant information to internal teams.
- Participating in continuous professional development activities to enhance regulatory expertise and staying informed of advancements in regulatory affairs and quality management.

**KEY SKILLS & EXPERIENCE**
- Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs.
- Deep understanding of regulatory requirements and processes for the Australian market, including ARTG management, TGA submissions, and compliance management.
- Experience