Danaher Corporation Regulatory Affairs Assistant (1 year contract) in Ho Chi Minh City, Vietnam
Support to manage all registration activities of all products distributed by Beckman Coulter in Vietnam/ Cambodia, ensure that all regulatory projects are completed within projected timelines.
Essential Jobs Functions:
Ensure on-time product registrations (new, renewal and variations) and handling all regulatory matters with Vietnam MOH. Assist and coordinate regulatory requirements for Vietnam channel partners. Assist the registration activities for Cambodia Channel Partner. Responsible for the analyzing upcoming product variations and determine whether variation registration is required. Enforce all Corporate requirements on compliance procedures and manage partners’ compliance requirements. Assist in the review/checking of regulatory documents to ensure completeness and correct to attain right first-time submission. Effectively create and update registration record into Regulatory database. Other registration administrative support work as assigned by RA Specialist.
Essential Job Requirements:
Education : Bachelor’s degree in Science/Pharmacy/Medical Engineering
Experience : Minimum 03 years-experience in Regulatory environment for medical devices.
Required skills : English Fluency, Strong computer application skills (Excel, Word, Powerpoint), strong knowledge of Vietnam regulations and ability to compliance, careful & detail oriented, able to meet deadlines and deliver on critical plans, team work oriented, results and process driven
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.