Associate/Senior Associate

3 weeks ago

Newcastle, New South Wales, Australia F. Hoffmann-La Roche Gruppe Full time
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

Healthcare is changing- radical innovation, increased openness to change, increasing patient empowerment, multiple sources of medical information, and pressure on public spending. As a result of all this, the needs of our stakeholders and how we engage them continue to evolve.

- Global reputable company | Market leader in Australia
- Supportive & dynamic team | Flexible ways of working
- 12 Months Fixed Term Maternity Leave Contract

Reporting to the Head of Regulatory and Quality Affairs, we are currently looking for a Regulatory Affairs Associate to join our team at our North Ryde head office. Regulatory Affairs Associate (RAA) is responsible for supporting regulatory compliance for the portfolio of products offered by Roche Diagnostics Australia (RDA). As a RAA, you will work across the business including the affiliate and global regulatory and quality networks, and you have a solid understanding of medical device regulations and quality management systems while being adept at managing multiple tasks in a dynamic environment.

Key responsibilities include:

- Align product registration activities with the local commercialization plan to support Customer Areas business objectives.
- Prepare and submit registration dossiers for IVDs and Medical Devices in the required format.
- Follow up on input requests from TGA to ensure successful product registration.
- Submit changes for approved products when there are updates, as necessary.
- Perform assessments on business impact when there are updates to products and inform relevant stakeholders accordingly.
- Regularly update the registration status of products in shared systems to maintain accessibility and clarity for all relevant stakeholders.
- Ensure compliance with TGA post-market regulations.
- Report Recalls and Adverse Events to TGA according to the required timelines.
- Stay informed about changes in global regulations, industry standards, and guidelines. Assess their impact on the company's products and processes and adjust strategies accordingly.
- Prepare for and support quality and regulatory related audits, including global quality audits.
- Assist in the provision of training and support to stakeholders regarding complaint-handling procedures.
- Assist in the provision of training and support to team members on quality and regulatory requirements. Foster a culture of compliance and continuous improvement.
- Ensure compliance with Quality and Regulatory related Objectives and Key Results (OKRs).

Who you are

- Tertiary qualification in science with 2-10 years' regulatory affairs experience with knowledge of the Australian regulatory environment for IVDs and/or medical devices.
- Understanding of Quality Management Systems (ISO 13485).
- Knowledge of Medical Device Vigilance reporting requirements, Industry Codes of Practice and other relevant standards and guidelines.
- Advanced knowledge of Microsoft Office suite: Word, Excel, PowerPoint, and Google suite.
- Strong attention-to-detail, interpersonal, communication, analytical and problem-solving skills.
- Good organisational and time management skills, with the ability to manage multiple projects simultaneously.
- Mindset and ways of working to support innovation, collaboration, authenticity and accountability for your actions and impact. You are passionate about patients and solution oriented within the regulatory landscape.

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 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.

We care about you - as a whole person. That's why we place your individual health, and professional growth at the very heart of what we do. Your well-being is one of our top priority, because when you're thriving, we all succeed. We offer access to mental health awareness and wellness initiatives that cater to your unique needs - because we understand that well-being is personal.

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 or workplace adjustment 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.

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