QARA Manager (Software)

We are looking for a QARA Manager responsible for supporting that company quality system is in compliance with applicable regulations, standards, internal procedures and best practices. The role will monitor and advise on the performance of the quality management system, produce data and report on performance. The role is responsible to support and facilitate the Regulatory Affairs activities to ensure that products comply and meet medical device regulatory requirements

Key Accountabilities:

• Cooperating with the QA/RA Director to co-ordinate quality assurance activities.
• Maintaining Quality Management system procedures.
• Cooperating with different company departments for implementing quality system
• procedures.
• Supporting internal and external Quality System audits.
• Participating in the continuous improvement process of the Quality System and
• collaborating in the annual Quality System Management Review
• Supervising software development process assessments.
• Monitoring and advising on how the quality system is performing.
• Disseminating knowledge about the Quality System.
• Ensuring and providing quality system training to all employees.
• Cooperating with Corrective and Preventive actions management.
• Coordinating Certification Entity, Notified Body and/or Competent Authorities
• interactions.
• Cooperating in post-market surveillance activities and complaints management.
• Participating in the selection of the QA team members.

Networking/Key relationships

To be determined based on department needs, to include interactions such as:

• Interaction with the QA/RA Director to co-ordinate quality assurance activities
• Interaction with different company departments for implementing audit plans and give
• support and advice on quality and regulatory matters.
• Interaction with Suppliers, Affiliates and Distributors
• External interactions with Notified Bodies and Competent Authorities for product
• regulatory compliance.

Education: Engineer, computer Science or other Technical carrier, or equivalent work

experience

Experience:

• Minimum of 5 years of work experience in a Quality department, preferably
• within the Healthcare sector.
• Experience scheduling and performing internal audits and CAPAs management
• Experience reviewing technical documentation and reports
• Extensive knowledge of software medical device regulations and standards
• Reviewing standard operating procedures and work instructions
• Able to detect improvement actions
• Solid knowledge on international medical device regulations and standards (EU
• Medical Device regulations, CE Marking, FDA 820.30 Design Control, ISO 13485,
• ISO 62304, ISO 14971, IEC 62304, IEC 62366, cybersecurity and privacy)

Additional Skills/Knowledge:

• Excellent communication skills
• Language: fluency English
• Previous experience in project design, validation, quality plans and risk
• management (including human factors engineering).
• Previous experience managing submissions, complaint systems and/or
• authorities reporting activities
• ISO 13485 certified auditor
• Experience in Regulatory issues for medical devices
• Capable for supporting and facilitating the Regulatory Affairs activities to ensure
• that products comply and meet medical device regulatory requirements

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and competencies:

• Leadership skills to create an environment where the QA team work together to deliver
• outstanding results
• Self-motivated with a high degree of initiative
• Self-management
• Organized with the ability to handle multiple priorities
• Time management
• Communication skills with the ability to interact effectively with all levels of
• management
• Flexible

What we offer:

• A meaningful project that will impact the quality of laboratory software medicine worldwide
• 3 days a week working from home
• Multicultural and friendly team
• Exciting opportunities for professional development.
• Ongoing training
• Social benefits: Canteen, nursery check, English training...
• All the benefits according to the chemical agreement