Regulatory Affairs and Quality Specialist (Melbourne, VIC)

The Difference You Will Make

STERIS is looking to hire a Regulatory Affairs Specialist in Australia! Reporting to the Regulatory Affairs and Quality Manager, you will be supporting the implementation, development and administration of STERIS’s global regulatory policy across product lines of the STERIS businesses by preparing international regulatory submissions for STERIS (and its affiliates) product approvals and other necessary tasks to meet Australian and New Zealand pre- & post-market requirements. You will also provide support for plans to achieve identified corporate regulatory policy objectives. You will keep abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or STERIS’s business directly.

What You Will Do

• Identify regulatory requirements for new products or product enhancements early in the product development cycle. Collect regulatory intelligence for Australia and New Zealand.
• Gather information to support regulatory submissions and prepare regulatory submissions in a complete and thorough format to support STERIS product claims.
• Coordinate compulsory testing in Australia and New Zealand when required.
• Review product revision requests to ensure compliance with regulatory requirements and assess new product launch requirements.
• Work with product teams to develop regulatory strategy based on submission requirements.
• Review and approve labeling and marketing literature, and work with the Unique Device Identification (UDI) team to comply with Australia/New Zealand labeling and UDI requirements.
• Support Regulatory Affairs and Quality Manager and other cross-regional Regulatory Affairs staff with all regulatory and compliance matters and conduct timely activities assigned.
• Work with internal stakeholders to identify key initiatives affected by present or emerging policies and develop and recommend government affairs policy positions to upper management.
• Lead the recall and adverse event reporting in Australia/New Zealand and work with the Compliance team to adhere to the regulation for recall and adverse event reporting.
• Properly archive all paper and electronic submission documents and follow Document & Record Management practices.
• Safeguard company confidential information by appropriately storing, retrieving, and disseminating such information only to authorized personnel.
• Apply for import permits and Work Cover Plant Design registrations as needed.
• Ensure ISO 13485/ISO 9001 quality system operates in compliance with applicable regulatory standards and participate in audits/inspections and document control.
• Issue and track Corrective Action/Preventative Action (CAPA) and report on CAPA effectiveness.
• Gather and analyze quality data for Quality Management Reviews.

What You Will Bring

• Bachelor’s Degree in Healthcare or Medical Science related disciplines.
• Solid experience with good track record in Australia & New Zealand Regulatory Affairs & Quality/ QMS Requirements (2-3 years)
• Familiar with the standards and regulations of TGA. 
• Working knowledge in ISO 9001/ ISO 13485.
• Familiar with Change Management, Risk management; exposure in Mergers, Acquisitions and Divestitures will be an advantage.

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