Director Quality Assurance Regulatory Affairs

We are looking for an experienced Quality Assurance & Regulatory Affairs director

For a fast  growing medical company.

The role entails the responsibility for managing quality systems development and

maintenance and coordinating regulatory activities for medical company

The immediate need and focus will be in Quality Systems, with the Regulatory responsibilities increasing over time.

Strong leadership and team skills will be important to guiding and aligning the internal team and external consultants.

Responsibilities

• 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

documented

• 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 management

• 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 quality

• 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 actions

• 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

Authorities:

• Approval of company products (compliance with regulatory and quality requirements)

• 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

Requirements:

• 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.