Regulatory Affairs And Quality Systems Specialist

Job Description:
This is a fantastic opportunity to commence or extend your career in Regulatory Affairs/Quality Systems and joining our head office team to be part of our global organisation.
We are currently seeking a highly driven team player to join our team in a full-time permanent capacity. Extensive training will be provided.
About Applied Medical
Applied Medical is a new generation medical device company with a proven business model and commitment to innovation that has fueled our rapid growth and expansion worldwide. What connects us all is our mission to improve the affordability and accessibility of high-quality healthcare by delivering innovative technologies that enhance clinical care. Be part of the growing Australian and New Zealand arm of our global organisation, that makes decisions locally for what is right for patients, customers, our team, community and environment.
Join the Applied Medical family today!
About This Role:
The Regulatory Affairs and Quality Systems Specialist, based in the Australian headquarters in Brisbane, Stafford. reports to the Regulatory Affairs and Quality Systems Manager and supports all pre-market and post-market regulatory activities for Applied Medical Australia and New Zealand’s (ANZ) existing products, whilst participating in quality related activities in the region to ensure compliance to the company’s Quality Management System and local and international regulations, legislation and standards.
Skills and Experience:

• Bachelor qualification in Engineering, Biomedical or biological sciences or previous experience in regulatory and/or quality positions.
• High level of IT literacy including intermediate Microsoft Excel and Word, along with demonstrated ability to learn other programs quickly; and
• Previous use of SAP or software is desirable.

Responsibilities include:

• Ensure Applied Medical’s agreed quality standards are maintained with regard to its products, procedures, policies, operations, and customer contact;
• Respond to questions and act as a liaison to customers, regulatory authorities, suppliers and internal teams and authorities;
• Manage and participate in projects to identify and implement systems to improve the Quality system and Regulatory compliance in accordance with national and international standards and regulations;
• Accurate processing of documents related to RA/QS;
• Create and update SOPs and Job Aids as required.

You Have:

• Strong attention to detail and accuracy;
• Self-management, organisational and time management skills;
• Analysis and problem-solving skills;
• Excellent written and oral communication skills; and
• Ability to work independently and collaboratively as part of a team.

Remuneration:
Salary package comprised of base salary and participation in a company bonus scheme, based on achievement in your role.
Other benefits:

• Conveniently located office in inner north, free parking available and close to transport;
• Work for a fast-growing organisation, who has a significant and sustainable impact on the healthcare industry;
• A collaborative work environment with a learning and development culture and philosophy of development of our team members;
• Mentorship with ongoing learning and development opportunities;
• Supportive and consultative executive management; and
• EAP program and other internal team member benefits and programs.

Please follow links to apply.