Job Title: Regulatory Affairs Specialist
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
Reporting to the Regulatory Affairs and Quality Manager, within the Regulatory Affairs (RA) team, the incumbent is 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- & post-market requirements. The incumbent will also provide support for plans to achieve identified corporate regulatory policy objectives. Responsible for keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or STERIS's business directly.
What are Roles and Responsibilities?
As this is an exciting role the incumbent is expected to follow the regulatory requirements and processes for new products or product enhancements in Australia and New Zealand:
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.
Education Degree
Bachelor's Degree in Healthcare
Required Experience
The candidate should have experience in Supplier management.
Should be familiar with ISO 9001/ISO 13485.
Implement Continuous Improvement strategies, as deemed necessary.
Should keep abreast of all the updates in Regulatory and Quality landscape in Australia & New Zealand.
Should be familiar with Change Management, Risk management; would be good to have exposure to Mergers, Acquisitions and Divestitures.
Should be familiar with Microsoft Office Suite and other technological tools like SharePoint.
Preferred Experience
3-5 years solid experience with a good track record in Australia & New Zealand Regulatory Affairs & Quality/QMS Requirements. Fluent English in speaking and writing. English communication is necessarily required. Familiar with the standards and regulations of MFDS. Work in Medical Device related company and have the experience for Medical Device registration & QMS.
Skills
Positive working attitude and responsive.
Meticulous, precise, and analytical.
A self-starter and able to work independently with minimum supervision.
Good organizational, time management, project management, and problem-solving skills.
Excellent communication skill and a good team player.
Proficiency in English.
Able to work under time pressure to meet deadlines and accept sometimes overtime work to join in conference calls.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences, and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.
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