ULTRADENT PRODUCTS INC. is looking for new potential candidates to fill in for Regulatory Affairs Manager position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
Join an exciting team in a growing region for Ultradent Products International! The Regulatory Affairs Manager will be responsible for ensuring regulatory compliance within the Asia Pacific region, by managing the overall registration activities within the identified areas. This includes Southeast Asia, Sub-Saharan Africa and Australia/New Zealand. They will work in cooperation with HQ and the Global Regulatory Affairs Core Team. The ideal candidate will be a self-starter who enjoys working with a dynamic team to get the job done.
Duties and Responsibilities:
1. Supervise registrations for products and business licenses under the applicable regional laws which will include the creation and submission of regulatory documentation for product approval within the identified regions.
2. Work with distributors or UPI regional offices to maintain product licensure and certificates.
3. Monitor regional regulations for possible impact on the organization.
4. Responsible for monitoring product change notifications received from HQ and notifying regulatory authorities of changes when required.
5. Responsible for building and maintaining a credible relationship with regulatory authorities.
6. Help identify and implement process improvements to increase product registration process efficiencies.
7. Review and approve product labelling for compliance with regional regulatory requirements.
8. Able to manage GDPMD audit/report for Malaysia office
9. Perform product recall, field actions, or vigilance reporting as necessary.
Skills and Qualifications Required:
1. Ability to work independently to perform job functions.
2. Working knowledge of regional regulatory laws and guidance.
3. Ability to write technical regulatory submissions and correspondence to regulatory agencies.
4. Ability to work well in a cross-functional team setting.
5. Excellent written and verbal communication skills with preference for fluency in English, Mandarin, Thai and Vietnamese languages.
6. Computer skills including the ability to use MS Office Suite.
Ultradent Products, Inc., is a leading developer of high-tech dental materials, devices, and instruments worldwide. Ultradent’s mission is to improve the level of dental health care and to make dental procedures more predictable and efficient. Consistent with its mission, Ultradent works to improve the quality of life and the health of individuals through financial and charitable programs.
Ultradent evolved from a dentist’s quest to create more effective dental products. Dr. Dan Fischer's desire to develop more advanced dental products led him to create products that would set future industry standards.
Today, Ultradent has subsidiaries in Germany, Italy, Brazil, China, Japan, Malaysia, Australia and South Africa, employing over 1,600 individuals and manufacturing and packaging more than 500 materials, devices, and instruments.
Ultradent’s products are used worldwide by dentists, group practices, dental and veterinary labs, government agencies, and universities. Ultradent has continued its development efforts, holding dozens of patents and trademarks on unique products, materials, devices, and application techniques.
See what our colleagues have to say about Ultradent: https://www.linkedin.com/posts/ultradent-products-inc-_we-started-as-a-family-company-and-with-activity-6618924926072172544-RSSC
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