Senior Regulatory Affairs & Quality Assurance Specialist, Taiwan & Hong Kong

Summary

STERIS Taiwan is looking to recruit a Senior RA & QA Specialist. Reporting to the Senior Manager, Regulatory Affairs and Compliance, you will be a key member of the Regulatory Affairs team, supporting the development and implementation of regulatory policy positions for STERIS Taiwan and Hong Kong across various product lines. Your primary responsibility will be to prepare and manage regulatory submissions to obtain and maintain product approvals in Taiwan and Hong Kong.

You bring a strong understanding of the local regulatory environments, excellent communication skills, and the ability to collaborate effectively with cross-functional teams. You will ensure compliance with all relevant laws, regulations, and standards, facilitating the timely registration and maintenance of medical devices.

In addition, you will support corporate regulatory policy initiatives, monitor and report on key regulatory developments, and provide strategic insights to business leaders on issues that may impact STERIS’s operations or its Customers.

What You Will Do

• Identify regulatory requirements for new products or product enhancements early in the product development cycle. Provide regulatory intelligence and guidance on regulatory changes, trends, and requirements for Taiwan and Hong Kong.
• Work with line Manager and senior internal stakeholders to identify key initiatives, which may be affected by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management.
• Gather information to support regulatory submission and related compliance activities. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims.  Ensure accurate and timely completion of all regulatory documentation
• Manage multiple projects simultaneously, ensuring timely completion of regulatory milestones. Track project progress and communicate effectively and timely with Line Manager and Commercial Leader.
• Serve as the primary contact with the TFDA, MDD and other regulatory authorities in Taiwan and Hong Kong. Build and maintain strong work relationships with regulatory authorities and key stakeholders.
• Review product revision requests to assure compliance with regulatory and post market requirements. Assess new product launch requirements and provide the regulatory information according to the needs.
• Review and approve labelling and marketing literature, as needed. Work with UDI team together to meet UDI requirements.
• Support APAC Quality for Recall and Adverse Event in Taiwan and Hong Kong when there are the needs.
• Work with APAC Quality and cross-functionally with local team to assure the ISO 13485 and/or GDP quality system operates in compliance with applicable regulatory standards when there are the needs.
• Archive and maintain all paper and electronic submission documents properly in RA resources.
• Protect company confidential information by properly storing, retrieving, and disseminating such information only to those authorised.
• Apply for special access and/or other permits related to product/site, as needed.
• General admin, collecting forms, scanning, emails to finance and HR. Affix company stamp on finance declaration form and submit the original to banks. Affix company stamp on insurance forms and deliver to insurer. These responsibilities are shared by all members of the Taiwan office.

The Experience, Skills and Abilities Needed

• Solid experience in Regulatory Affairs, with a strong track record in Taiwan, experience in Hong Kong is a plus.
• Familiarity with Taiwan’s regulatory standards and regulations. Experience working in a Medical Device related company and with hands-on involvement in medical device registration processes.
• Fluent English, both spoken and written; strong English communication skills are essential.
• Administrative responsibilities are shared among all members of the Taiwan office, requiring strong teamwork and coordination skills.

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