• Responsible for the regulatory affairs and quality assurance requirements.
• To prepare, implement and maintain quality regulations
• Appointed as Management representative according to the ISO13485:2016 (5.5.2)
• To define the quality policy and control its implementation
• Responsible to ensure that processes needed for the quality management system are
• Control of equipment calibration and maintenance
• Continuous control of existing quality procedures and their effectiveness by means of
initiating and conducting Internal Quality Audits, and presenting the findings to the
• Control of documentation and quality records
• Analyze quality data and trends for management reviews
• Affirmation that the company products fulfill the requirements for standardization and
• Reports to the top management on the effectiveness of the quality management system and
any need for improvement
• Responsible to ensure the promotion of awareness of applicable regulatory requirements and
quality management system requirements throughout the organization
• Handling customer complaints and vigilance reports
• Handling of nonconforming products / materials, and follow-up of corrective and preventive
• Approval of a DMR (Device Master Record) for new products
• Comply and serve as the company’s PRRC instruction and guidance as specified in Article 15
of the EU MDR and MDCG 2019-7:
Register under EUDAMED website as the company PRRC
b) Ensure the conformity of the devices is appropriately checked, in accordance with the
quality management system under which the devices are manufactured before a device
c) Ensure that the technical documentation and the EU declaration of conformity, for each
of the Company’s products, are drawn up and kept up-to-date, in compliance with
(Article 10(4) of the MDR and Article 10(6) of the MDR, accordingly. Sign the
documentation as a way of approval
d) Ensure that the post-market surveillance obligations, including the provision of periodic
summary reports, post-market surveillance reports, PSURs, are compiled by the
Company within accordance with Article 10(10) and Article 83 of the MDR;
e) Ensure that the reporting obligations, including reporting of serious incidents, field
safety corrective actions and field safety notices, performed by the Company as
referred to in Articles 87 to 91 of the MDR are fulfilled.
f) Ensure that in the case of investigational devices, the statement referred to in Section
4.1 of Chapter II of Annex XV of the MDR is issued by the Company, that the device in
question conforms to the general safety and performance requirements apart from the
aspects covered by the clinical investigation and that, with regard to those aspects,
every precaution has been taken to protect the health and safety of the subject.
• Approval of company products (compliance with regulatory and quality
Control of processes in compliance with the applicable regulations
• Defines and maintains the quality infrastructure in the company
• Approval of qualification and validation activities
• To realize quality plans
• Sub-contractors and suppliers’ approval
• Training and qualifying the company employees
• Sub-contractors and suppliers’ approval
• Liaises with regulatory authorities
• Lot release
• Approve finished projects and ECOs
• Approve design reviews as part of the R&D plans
• Definition of testing, calibrating, maintenance and inspection procedures
• Approval of PMS processes
• Strong organizational and communication skills, both written and presentation.
• Able to work with a diverse group of individuals and styles, internally (employees)
and externally (consultants)
• Respect and adherence to timelines, self-motivated and willing to learn
• Bachelor’s degree in Engineering; or over 10 years’ experience of Regulatory and Quality
management in the medical device industry; a minimum of three years’ experience in quality
control function and 3-5 years management experience; or equivalent combination of
education and experience.
• ASQ ICQM certification preferred.
• Experience in Process Optimization and Variability Reduction/Cost Reduction Projects or similar.
• Regulatory knowledge specific to the FDA Quality System Regulations, ISO9001/ISO13485,
Medical Device Directive (MDD), Regulation MDR 2017/745 required, Japan, Canada, Australia
and other countries.
• Experience in process validation, working in a production environment would be advantageous.
• Proven ability of working in a cross-functional team environment.
• Excellent interpersonal and communication skills and high level of computer literacy.
• Certified auditor for medical devices systems preferred.