Regulatory Affairs/Quality Affairs Specialist

Req ID: 43753

Job Category: Regulatory Affairs

Taipei, TPQ, TW, 000000

Description:

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.

The Difference You Will Make

As our business grows, we are looking to bring in a Regulatory Affairs/Qualify Affairs Specialist to join our Taiwan office! You will be responsible for providing regulatory and quality support for all of STERIS business. This includes international regulatory submissions for pre-market approvals, license or Quality System Documentation (QSD) maintenance, and post-market surveillance. You will also stay abreast of the latest internal policy and regulation updates from the health authority and support the compliance activities as needed.

What You Will Do

• Identify the local regulatory requirements for license/QSD registration, amendments, authorization, renewals, and market access. Plan the submission strategy and achieve the timely approvals.

• Provide regulatory support to the internal and external stakeholders for business development, such as tenders, dealer management, and promotional materials review.

• Maintain the regulatory database in the Oracle system and SharePoint, and maintain the UDI information in the TFDA TUDID.

• Support the post-market surveillance, including field corrective actions, adverse events reporting, product complaints, periodic safety update reports, and CAPA tracking if needed.

• Work cross-functionally with the local team to support STERIS Taiwan office development. Develop and maintain the local quality maintenance system as required.

• Identify the key initiatives and actions to report back to the leadership team on the latest local policies and requirements.

Your Expertise

• Bachelor’s Degree with some solid experience in regulatory affairs/quality affairs profession.

• Familiar with Taiwan medical device-related regulations.

• Work experience in a multinational medical device or pharmaceutical company will be an advantage.

• Fluent in English speaking and writing.

#LI-KG1

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.

Req ID: 43753

Job Category: Regulatory Affairs

Taipei, TPQ, TW, 000000

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