Senior Regulatory & Quality Affairs Specialist

Reporting to the Regulatory Affairs and Quality Compliance Senior Manager within the Regulatory Affairs (RA) team you are responsible for supporting the implementation development and administration of STERISs 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 SEA countries - Vietnam Thailand Indonesia Philippines Myanmar Cambodia Brunei Laos; pre- & post market requirements. You 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 STERISs business directly.

• Identify regulatory requirements for new products or product enhancements early in the product development cycle. Collect regulatory intelligence for SEA countries - Vietnam Thailand Indonesia Philippines Myanmar Cambodia Brunei Laos.
• 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 SEA countries - Vietnam Thailand Indonesia Philippines Myanmar Cambodia Brunei Laos 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 SEA countries - Vietnam Thailand Indonesia Philippines Myanmar Cambodia Brunei Laos 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.
• Work with direct supervisor and other cross-functional internal stakeholders to identify key initiatives which may get affected by present or emerging policies. As part of this develop and recommend government affairs policy positions to upper management.
• Lead the recall and adverse event reporting in SEA countries - Vietnam Thailand Indonesia Philippines Myanmar Cambodia Brunei Laos.
• 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 authorized.
• 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 / 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.
• Should be familiar with ISO 9001/ ISO 13485.
• Implement Continuous Improvement strategies as deemed necessary.

Required:

• 5 -7 years solid experience with good track record in SEA countries - Vietnam Thailand Indonesia Philippines Myanmar Cambodia Brunei Laos Regulatory Affairs & Quality/ QMS Requirements.
• Fluent English in speaking and writing. English communication is necessary required.
• Fluency in any of the Local languages of SEA countries - Vietnam Thailand Indonesia Philippines Myanmar Cambodia Brunei Laos.

Preferred:

• Familiar with the standards and regulations of SEA countries - Vietnam Thailand Indonesia Philippines Myanmar Cambodia Brunei Laos.
• Work in Medical Device related company and have experience for Medical Device registration & QMS.
• familiar with Change Management Risk management; exposure to Mergers Acquisitions and Divestitures.

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