Senior Quality & Regulatory Affairs Specialist

An exciting Senior Quality & Regulatory Affairs Specialist job has arisen in a leading firm in Ho Chi Minh City Vietnam.

About the Senior Quality & Regulatory Affairs Specialist Role:

Reporting to the Managing Director, Senior Quality & Regulatory Affairs Specialist oversees and supervises regulatory affairs in full compliance with local regulations. Establish company’s quality management system locally by monitoring processes, training staff, and implementing improvement measures.

Key Responsibilities:

• Develop plans for ensuring timely registration of new/updated products
• Identify and recommend options for engaging local RA partners to cope with changes to the regulatory framework
• Supervise and monitor local RA partners engaged to support company’s product registration needs
• Participate in meetings with local competent authorities and local technical committees, anticipating trends in regulatory rules applicable to company business
• Establish strong working relationships with the following parties
• Government: Ministry of Health, Local Health Services
• External: Fellow RA professionals, unofficial industry committees, official industrial bodies, market consultants
• Internal: Medical sales, Operations, financial controlling, overseas RA stakeholders
• Partners: Sales Channel Partners, RA consultants, contractors
• Oversee matters associated with product recalls, product advisory notices, incident investigations or reporting
• Implement and maintain effective processes to meet IMS (integrated management system) objectives, to provide evidence of compliance with relevant quality, occupational health and safety and environmental (HSE) directives, standards, technical and legislative requirements
• Establish, maintain and monitor required fault signalling and improvement systems for quality, HSE systems consistent with the related global processes, including partnering with other functions:
• medical device incident reporting, complaint handling, corrective and preventive actions program, system for signalling unsafe situations, hazard identification and risk assessment system, incident and accident registers
• Analyse and report to management on the effectiveness and efficiency of IMS systems: corrective action program, vigilance and RAs, product recalls, advisory or warning notices, customer complaints, quality planning, internal/external audits, non-conforming products and incident and accident register
• Implement and maintain effective controls for non-conforming product handling, reporting, labelling and disposition, including partnering with other functions
• Ensure implementation of field corrective actions and quality improvement projects (e.g. Failure-On-Arrival)
• Support, plan and organise external audits by notified bodies or customers in collaboration with Regional Quality Manager
• Establish and maintain an appropriate local internal audit program, perform periodic inspections and internal audits in collaboration with Regional QRA Manager(s)
• Ensure elimination of findings from internal and external audits with appropriate immediate actions, root cause analysis, corrective actions and effectiveness checks
• Provide relevant training for quality, HSE system related matters
• Collaborate with management, process owners and other colleagues in creation, maintenance and retention of policies, standards, forms and other relevant system documentation
• Provide, maintain and monitor a current library of applicable policies, standards, directives, technical documents, approved codes of practice, method statements, quality plans, risk assessments, incident and accident reporting documents, fire and building records, and other quality, HSE system documentation as required

To succeed in this role, you must have good communication skills in English.

Key Requirements:

• University degree or comparable business experience
• Minimum three years of working experience
• Experience with Regulatory Affairs
• Strong Knowledge of local regulatory framework
• Knowledge of quality management system
• Expertise in software applications (e.g. MS Office)
• Communication skills
• Strong influencing skills to lead executive management, peers and subordinates

This leading company needs no introduction and is recognised as the leader in their field of expertise. The culture is demanding but if you are confident and have a can-do attitude the potential rewards are significant.

If you are driven and looking for a new challenge, this is the role for you.

Apply today.