Quality Assurance and Regulatory Affairs (QARA) Manager

The Quality Assurance and Regulatory Affairs (QARA) manager will be responsible to implement, manage and improve all quality and regulatory affairs related processes and the ISO13485:2016 complaint quality management system (QMS).The QARA manager will advise senior management on the status of the processes and QMS, for compliance with international and local medical device standards and regulations.

QUALIFICATIONS, EXPERIENCE AND SKILLS:

Required:

• 3 -5 years minimum experience in document control within a certified quality management system (QMS)
• Advance proficiency: ISO 13485:2016
• Candidate must possess intermediate usage skills with Microsoft Office (Outlook, Excel, PowerPoint, etc.)
  
  
  

Preferable/Advantageous:

• Bachelors degree in a microbiology, biochemistry or related field or engineering
• Intermediate proficiency: Medical device CE MDD and MDR
• Advanced proficiency: ISO13485:2016
• Advanced proficiency: SAHPRA requirements
• Intermediate proficiency: BOTSWANA (BOMRA)
• Experience in medical device manufacturing and related concepts of working in a cleanroom.
• Experience in sterilization of medical devices (EO/Gamma sterilization, compliance to ISO 11135/11137).
• Experience in electronic device design and manufacture.
  
  
  

DAILY DUTIES AND RESPONSIBILITIES:

• Document and process change management implementation and daily record control including maintenance of the internal document register. This comprises of the withdrawal, re-issuing, disposal and archiving of documents including all electronic platforms.
• Timeous recording, monitoring, reporting, and feedback on the complaints and PCAR (CAPA) systems.
• Ensure that required regular meetings are planned and applicable reports are available in advance. This include but may not be limited to complaints, QA, management review etc. Minutes must be taken and shared for input from meeting attendees. The final report and minutes to be shared with all relevant persons.
• Support other team members in various projects as assigned and applicable or requiring input from quality assurance and regulatory affairs.
• Ensure customer or user training records are filed and easily referenced for audit purposes.
• Effectively implement and maintain SAHPRA, FDA and other country specific applicable regulations and guideline for distributed and manufactured products.
• Actively identify possible areas of improvement and report this to top management for consideration.
• Ensure the design file for manufactured products are updated and all required notifications of change performed in compliance with all requirements.
• Act in the role of authorised representative for the Xpella company for SAHPRA.
• Act in the role of management representative for ISO134885:2016 compliance.
  
  
  

MONTHLY DUTIES AND RESPONSIBILITIES:

• Responsible for the review and update of the external documents register including purchasing of new standards. Initiate and perform a review and GAP analysis on new or revised external documents and implement or guide process owners in the requirements and changes to ensure compliance.
• Review monthly environmental data collected by the quality assistant to ensure any out-specification results are identified and reviewed for impact on products that is distributed from the warehouse.
  
  
  

AD-HOC AND PROJECT TYPE DUTIES AND RESPONSIBILITIES:

• Writing of the management review report include statistical analysis (available 2 weeks before scheduled meeting), meeting notes and follow-up/documentation of feedback on open actions.
• Timeous document, monitoring and reporting on the non-conforming product systems including deviations and concessions during and after manufacturing runs. The quality assistant will provide all the required information.
• Participate in the internal and external audits as per the audit schedule. Ensure that relevant persons and management is aware of any audits.
• Track and follow up or record feedback on the annual quality objectives and KPIs.
• Quality system training and completion of training records.
• Perform device registration in the local and SADC markets.
• Update the current NuAngle Medical QMS system to the format of the Xpella company QMS system (process based). Update the documents with the new NuAngle logo/header (brand changes), including NuAngle updates in Xpella documents.
• Create QMS system (import and distribution) for NuAngle Solutions, Aesthetics and Technologies for ISO13485:2016 certification purposes, based on the current system and processes already in place.
• Complete required application documents and submission to SAHPRA to obtain and maintain licenses.
• Maintain and plan the companys internal quality audit program. Ensure that required non-conformances are documented and addressed in a timeous manner.
• Attend all SAMED and MDMSA Meetings and Feedback to management.
  
  
  

Manufacturing:

• Ensure the cleanroom review is completed with the quality assistant before manufacturing commences.
• Ensure that batch record control documents are completed daily during ad-hoc manufacturing. In the process, aid the quality assistant with management of the manufacturing team if required. Also aid in manufacturing process in terms of physical device assembly, quality control checks, and product release. Ensure training records of manufacturing is completed with the batch record forms.
  
  
  

Purchasing and Control of Suppliers and Service Providers:

• The quality assistant is responsible for monitoring the manufacturing suppliers and service providers. As the QARA manager, ensure that it is being implemented. In addition, the control of other suppliers and service providers will be the responsibility of the QARA manager.
• Initiate and maintain a record of the QARA contractual requirements for suppliers and service providers.
• Ensure that QA agreements are in place with suppliers with regards to the specific requirements for NuAngle Group and Xpella company with regards to access to documentation and information for product registration, change management and complaint/recall/communication timelines.
• Ensure purchasing specifications are updated in-line with design documentation and changes throughout the lifetime of the manufactured devices.
  
  
  

Risk Management:

• Maintain risk management process for the business and ensure it is updated when required.
• Recording risk assessment matrix and writing of risk management report for manufactured devices based on ISO14971.
• Update risk management file when new risks are identified through:
• Post Market-surveillance feedback
• Annual review of adverse event data bases
• Post-production information
• Post-marketing information
  
  
  

Marketing and product labelling/IFU

• All marketing material must be approved after review by the Regulatory Affairs Manager, for correct use of regulatory logos and information for manufactured product.
• All product labelling and IFU must be approved by the Regulatory Affairs Manager including labels printed for manufacturing runs.
• Compilation of medical device files
• Ensure regulatory conformance and requirements for the design and medical device files are met during all stages of product life cycle.
• Create and maintain medical device file contents.
• Submission of medical device file to notified body or health authorities when required.
• Perform health authorities applications in any territory the device will be sold.
  
  
  

Post market surveillance, clinical evaluation, usability vigilance, reporting and recall, device marketing and registration

• The QARA Manager is responsible to maintain and capture activities and documents as per the relevant procedure for each process in compliance with the country specific requirements for markets into which the manufactured product will be sold.
• Registers and records applicable to these procedures must be maintained.
  
  
  

Design and development

• The QARA Manager is responsible to create, update and maintain design and development files of the manufactured product in compliance with all applicable standards.
• The QARA manager will co-ordinate the design team and ensure all required documents are created and available in the product design files.
  
  
  

Heads up!

Were on the hunt for top talent on behalf of our awesome client! If this sounds like your kind of gig, hit that apply button! Only shortlisted candidates will be contacted, and we keep things 100% confidential. Were all about equal opportunities hereeveryones welcome!