Address
Form of workWe are looking for a new part time Team Member in our Regulatory Affairs Department:
- Parental leave contract
- Part time role (approx. 23 hours per week. Please, include in your cover letter your preference of working hours to achieve this.)
- Experience in a Regulatory Affairs role
- May come from various medical device industry backgrounds (cardiac, orthopedics, etc.)
Benefits
- Be coached and developed by a local experienced Team Member and mentored as part of the global Regulatory Affairs team.
- Free on-site parking.
- Join us, we are a Global organization that is renowned for innovation and quality.
- BIOTRONIK is a privately-owned global company of over 10,000 employees.
- We strive to have a corporate culture we are proud to talk about.
Our culture
At BIOTRONIK we pride ourselves on our ability to have long-lasting positive impacts on our patients.
Our solution focused mindset produces sustainable growth and innovation, complementing our inclusive and supportive teamwork orientated culture. At our core we are working towards creating medical technology that saves lives on a global scale, led by our vision, ‘excellence for life’.
A day in the life
- Perform product registration activities (TGA, Medsafe) for all of BIOTRONIK’s business units
- Ensure ongoing compliance of the company’s products and services
- Collaborate with the regulatory teams at our headquarters in Europe to ensure the accuracy and quality of the documentation
- Administer the customer complaints process
- Manage the QMS including audits, resolving non-compliances and support improvement of the systems and procedures
About BIOTRONIK
You will join a team that is committed to helping people with heart and vessel diseases live healthy, fulfilling lives.
This immense responsibility motivates thousands of other BIOTRONIK employees worldwide to develop new cardiovascular and endovascular medical technologies that physicians trust to save and improve patient lives.
Our unique and reliable products include:
- Arrhythmia monitoring
- Implantable pacemakers and defibrillators products
- Coronary and peripheral vascular intervention products
- Digital health services
- Ablation and diagnostic catheters
- Spinal cord stimulation systems
As one of the world’s leading innovator of cardiovascular Medical Devices, BIOTRONIK is headquartered in Berlin, Germany, and represented by our global workforce of more than 10,000 employees.
Qualification and Experience
We are looking for a new Team Member who may come from a broad background including:
- Degree in Engineering or Science
- Knowledge of the regulatory requirements for all classes of Medical Devices in Australia and New Zealand
- Intermediate knowledge of the Cardiac Rhythm Management and Vascular Intervention businesses
- Working independently towards timeframes and deadlines
- Good understanding of relevant TGA guidelines
