Regulatory Affairs & Quality Specialist

Summary

Reporting to the Senior Manager, Regulatory Affairs and Quality Compliance, within the Regulatory Affairs (RA) team, you will be responsible for supporting the Implementation, development and administration of STERIS’s global regulatory policy positions 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- and post-market requirements. You will also provide support for plans to achieve identified corporate regulatory policy objectives. In addition, you monitor evolving regulatory landscapes and provide regular updates and insights to internal stakeholders and business leaders on regulatory developments that may impact Customers or STERIS’s operations.

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. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims. Coordinate compulsory test in Australia and New Zealand when there is the need.
• Review product revision requests to assure compliance with regulatory requirements. Assess new product launch requirements and provide regulatory information according to the needs.
• Work on product teams to develop regulatory strategy based on regulatory submission requirements.
• Review and approve labeling and marketing literature, as needed. Work together with UDI (Unique Device Identification) team to comply with Australia / New Zealand labeling and UDI requirements.
• Support Senior Regulatory Affairs and Quality Compliance Manager and other cross- regional Regulatory Affairs staff with all regulatory and compliance matters. Conduct timely activities assigned.
• Collaborate with your direct supervisor and colleagues from various departments to identify key projects that may be affected by current or future policies. As part of this, develop and recommend government affairs policy positions to upper management.
• Lead the recall and adverse event reporting in Australia / New Zealand. Work with Compliance team and follow the regulations for recall and Adverse Event reporting.
• Archive all paper and electronic submission documents properly and follow Document & Record Management.
• Protect confidential company information by properly storing, retrieving, and disseminating such information only to those Authorised.
• Applying for import permit and Work Cover Plant Design registrations, as needed.
• Work with Senior Regulatory Affairs and Quality Compliance Manager and cross-functionally with local team to assure the ISO 13485/ ISO 9001 quality system operates in compliance with applicable regulatory standards, including participation in internal and external audits/inspections as well as supplier audits / inspections.
• Development and maintenance of local quality system processes, ISO 13485/ISO 9001 and / or customer audit facilitation and document control.
• Utilize CAPA (Corrective Action / Preventative Action) system, including issuance of CAPAs, tracking of open CAPAs, and reporting on CAPA effectiveness.
• Gather and trend quality data for Quality Management Reviews.
• Supplier management.
• Implement Continuous Improvement strategies, as deemed necessary.
• Keep abreast of all the updates in Regulatory and Quality landscape in Australia & New Zealand.

The Experience, Skills and Abilities Needed

• 3–5 years of relevant experience in Regulatory Affairs and Quality within the medical device industry.
• Proven experience working with Australia & New Zealand regulatory frameworks, exposure to Southeast Asia (SEA) markets is an advantage.
• Hands-on experience with medical device registration and QMS implementation/maintenance.
• Strong knowledge of ISO 13485 and/or ISO 9001 standards.
• Familiarity with change management and risk management processes.
• Experience or exposure to Mergers, Acquisitions & Divestitures is a plus.
• Proficient in Microsoft Office Suite and collaboration tools such as SharePoint.
• Fluent in English (both written and spoken) with strong communication skills.
• Ability to work in a fast-paced environment, manage deadlines, and accommodate occasional overtime for global coordination.

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