Assistant Regulatory Affairs Manager - #1132029

Job Description

1.     Maintain Quality Management System, Certification and Registration in compliance to regulatory requirement (ISO9001, ISO13485, US FDA, cGMP)

2.     Product registration in US, UK, Japan, Singapore, and other countries

3.     Environmental control, monitoring and reporting, not limited to cleanroom air/surface microbial, temperature & humidity, particle count, product bioburden, 3rd party certification, PEST control, LAL testing.

4.     Manages failure investigations, including customer complaints and non-conforming events, and implementation of effective preventive and corrective actions.

5.     Manages sterilization, transportation, stability, biocompatibility, and product release activities

6.     Maintain current regulatory affairs and technical knowledge and perform gap analysis and QMS system implementation and training to staff for compliance

7.     Maintain library of product and process-related reference standards, regulations, guidance’s, clinical articles.

8.     Guidance in risk management review & approval, develop risk management strategies & approaches.

9.     Report FDA advisory notice and MDR

10.   Lead 8S program and maintain good 5S housekeeping and safety at workplace

11.   Drive Operational Excellence program in continiuos improvement

12.   Perform any other duties as assigned from time to time

Job Requirement

• Minimum 3 years experience in either domestic and regional regulatory affairs in medical device industry, preferably molding industry.

• Familiar in QC Tools, FMEA, SPC, Poka Yoke

• Knowledge in Sterilization, Micro-lab, bioburden and endotoxins test will be added advantage

• Certified Internal Auditor, 6 sigma trained

• Team player

• Good communication skills

• Good analytical and problem solving skills

• Good eyesight, Proficient in English and Chinese, both veral and written