Regulatory Affairs and Quality Associate at F. Hoffmann-La Roche Ltd - Poland

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

19 Mar, 26

Salary

0.0

Posted On

19 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Quality Management Systems, Analytical Skills, Problem-Solving, Effective Communication, Presentation Skills, Medical Device Vigilance, ISO 9001, ISO 13485, Project Management, Training, Collaboration, Continuous Improvement, Advertising Compliance, Stakeholder Engagement

Industry

Biotechnology Research

Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As a Regulatory Affairs and Quality Associate, you will be responsible for supporting regulatory and quality compliance for the portfolio of products offered by Roche Diabetes Care Australia and Roche Diagnostics Australia (RDA). You will work across the business, including local and global regulatory and quality networks, to manage multiple tasks in a dynamic environment. Your core mission is to ensure medical device regulations and quality management systems are upheld to maintain our license to operate and support our business strategy. Shape the Future of Diagnostics: You will play a critical role in bringing innovative IVDs and medical devices to the Australian market by aligning product registrations with local commercialisation strategies. Broad Strategic Impact: This position offers the opportunity to work across diverse internal communities—including Strategy, Access, and Innovation—while interacting directly with key external bodies like the TGA and Department of Health. Drive Excellence and Innovation: You will contribute to the optimisation of Quality Management Systems and foster a culture of continuous improvement within a global regulatory network. What you will be working on includes: In this role, you will be deeply involved in the lifecycle of our IVDs and medical devices, from initial registration to post-market vigilance. You will: Prepare and submit registration dossiers for new products and changes to marketed products in a timely manner, aligning with local commercialisation plans. Interact with regulatory agencies, such as the TGA, and follow up on input requests to ensure successful product registrations. Assess the business impact of product updates or regulatory changes and inform relevant internal stakeholders accordingly. Manage post-market compliance, including reporting recalls and adverse events to the TGA within required timelines. Maintain accurate registration records in shared systems to ensure accessibility and clarity for all stakeholders. Monitor and implement global Quality Management System processes locally, ensuring practices align with global best practices. Prepare for and support audits, including global quality audits and regulatory inspections. Contribute to the optimisation of quality systems, focusing on the standardisation and implementation of robust processes. Foster a culture of compliance by providing training and support to team members on quality and regulatory requirements. Ensure advertising compliance by monitoring marketed products against the Therapeutic Goods Advertising Code. Who you are: You are a detail-oriented professional with a passion for quality and a solid understanding of the Australian regulatory landscape. You bring: Educational Foundation: An undergraduate degree in Science or an equivalent qualification. Regulatory Expertise: Relevant experience and knowledge of the Australian regulatory environment specifically for IVDs or medical devices. Systems Knowledge: A strong understanding of Quality Management Systems, including ISO 9001 and ISO 13485 standards. Strategic Thinking: Strong analytical and problem-solving skills, with the ability to manage multiple complex projects simultaneously. Effective Communication: The ability to convey complex regulatory information clearly and collaborate effectively with cross-functional teams. Presentation Skills: Proficiency in presenting key considerations and decision-points to business stakeholders. Compliance Mindset: In-depth knowledge of Medical Device Vigilance reporting, Industry Codes of Practice, and the Therapeutic Goods Act 1989. This role is only open to candidates that have full eligibility to live and work in Australia. We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in-house Talent Acquisition team. What we offer Roche offers rewarding growth opportunities, a competitive remuneration package and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders. Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients. Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, respiratory disease and diabetes. We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. We welcome applications from all people and encourage you to advise of any individual circumstances that may require consideration. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The Regulatory Affairs and Quality Associate will support regulatory and quality compliance for Roche's product portfolio, ensuring adherence to medical device regulations and quality management systems. This role involves preparing registration dossiers, managing post-market compliance, and interacting with regulatory agencies.