Market Quality Assurance and Regulatory Affairs
Work Location: Ho Chi Minh
Job type: Full-Time
Salary: 63,000,000 - 70,000,000 VND / Monthly
Here’s where you’ll demonstrate your competencies:
- Develop, own and drive new business strategies across Vietnam that lead to business growth.
- Implements and oversees the ASP Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance.
- Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics.
- Responsible for or together with QA personnel be involved in processes such as maintenance of distribution records, complaint handling, maintenance and service agreements, field actions, AE reporting, and reporting changes to local authority, etc.
- Participates and hosts internal and external audits. May serve as liaison between local health authority and the business.
- Maintains a comprehensive audit readiness program to ensure internal and external quality compliance.
- Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring, product release).
- Maintains quality oversight of any local required establishment licenses, or QMS certifications.
- Maintains local supplier/vendor selection, qualification, and audits.
- Maintains quality records and adherence to records retention policies and procedures.
- Maintains quality oversight of field service processes/procedures.
- Maintains quality training program with respect to quality system elements.
- Establish corrective and preventive actions to mitigate potential or actual noncompliance risks.
- Assesses product quality issues and escalates to upper management through established processes.
- Ensures timely post-market surveillance & vigilance (Field Actions and Product Complaints) management
- Work independently and efficiently with regional and global team for Vietnam regulatory needs;
- Set up short-term and long-term regulatory strategy and efficiently implement the strategies to ensure successful market access of new products and transitioning/maintaining/updating the existing licenses/approvals per target timeline, and regulatory compliance;
- Establish and implement local procedures to ensure regulatory submissions, approvals are the most efficient per regulation requirements and international guidance where applicable;
- Develop, initiate, and revise procedures to regulatory affairs to ensure compliance to regulations of the medical device and disinfectant products and company policy;
- Ensure the regulatory compliance (promotions material, graphics, complaints, AEs, field actions, health authority audit, etc.);
- Represent the company to interact with regulatory authorities as appropriate; proactively collect, monitor, analyze, interpret, communicate product relevant regulations, industrial standards, national standards, influence local regulations and direct interact with regulatory agencies on defined matters.
- Provide strong support to audit, post market surveillance activities from regulatory perspective;
Perform other duties assigned as needed
Here’s what we’ll need from you:
- Minimum of 6 years of experience in medical device or pharma regulated environment in the areas of Quality, Regulatory Affairs, R&D, Manufacturing, or related field.
- At least 3 years’ experience in the Medical Device industry
- Regulatory Affairs Certification (RAC) and/or Certification in Medical Device Regulatory Affairs preferred
- Bachelor’s degree in Engineering, Life Sciences, or equivalent field required.
- Demonstrated knowledge of the local regulatory standards and regulations, FDA 21 CFR 820, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA, ISO 13485, ISO 9001, ISO 14971.
- Knowledge of relevant medical device laws, regulations, guidelines and standards, in particular, but not limited to applicable local regulations and guidelines and international regulations such as the ISO 13485 program guidelines and implements via suitable processes.
- Must have a successful track record of supporting project teams and preparing submissions for Class II and Class III medical devices.
- Ability to effectively negotiate and influence above, below and across the organization
- Ability to work and communicate in a cross-cultural environment.
· Must have excellent written, verbal communication and presentation skills.
- Highly developed influence, interpersonal, communication and conflict resolution skills
- Ability to interact with all levels and disciplines within the organization
- Must be able to work on multiple priorities and tasks simultaneously, while acting in a decisive manner and demonstrating a bias for action
- High sense of urgency, adaptable to meet rapidly changing priorities
- Proven analytical/quantitative skills
- Project management skills, with the ability to drive change and influence decision making through multiple levels.
- Fluency in business English.