Head of QARA Department

ABOUT THE POSITION

The QARA Department oversees the management systems for Therapixel. The Head of QARA Department define the regulatory strategy for Therapixel products in collaboration with top management and continuously monitors and communicates regulatory changes that impact Therapixel. The Head of QARA is responsible for Therapixel’s compliance with applicable quality standards and medical device regulation.

As our Head of QARA Department your Missions and Responsibilities, will be:

• Overall responsibility for developing, implementing and maintaining the Therapixel Management Systems.
  • Applying, maintaining, monitoring, and adapting the policies of Therapixel
  • Organizing management reviews, internal and external audits
  • Creating and assessing non-conformities in response to problems detected from sources such as customer complaints, device problems, supplier problems etc.
  • Creating Corrective and Preventive Actions (CAPA) and monitoring progress.
  • Managing and controlling changes made to the Management Systems.
  • Coordinating Field-Safety Corrective Actions.
  • Gathering post-market data
  • Keeping technical files updated.
• Liaison with Notified Bodies, Certification Bodies and Competent Authorities for device registration, certifications and updates.
• Review of applicable regulations and ensuring Therapixel is compliant.
• In collaboration with top management, defines Therapixel’s regulatory strategy.
• Ensure Therapixel products are developed and marketed according to regulations.
• Maintains up-to-date his/her knowledge of standards and regulations and anticipates regulatory changes.
• Foster a Quality culture within Therapixel through communication of policies and training to staff.
• Work with the Data Privacy Officer (DPO) and SysAdmin to implement the information security policy.
• Communicating with competent authorities on matters of medical device vigilance.
• Ensuring the conformity of the device in accordance with the quality management system under which the devices are manufactured, before a device is released.
• Fulfilling the reporting obligations referred to in the European Medical Device Regulation

It’s necessary to have:

• Scientific Degree, biomedical engineering preferred
• At least four years of professional experience in regulatory affairs and quality management systems relating to medical devices, Software as a Medical Device (SaaMD) preferred
• Knowledge and experience of medical device standards and regulations, especially applied to software:
  • ISO 13485
  • ISO 14971
  • IEC 62304, IEC 62366
  • US regulations: 21 CFR Part 820 Quality System Regulations
• Knowledge and experience of EU medical device regulation (MDR)
• Additionally, knowledge of information security standards and regulations would be appreciated:
  • ISO 27001
  • ISO 27018
  • Applicable FDA guidance on cybersecurity applied to medical devices, including ANSI UL 2900-2-1.
  • HIPAA and GDPR

Some essentials you need to have:

• Proven ability to conduct regulatory submissions to the FDA.
• Good organizational and planning skills.
• Attention to detail.
• Ability to write clear and effective procedures.
• Proficiency with MS Office (Word, Excel, Powerpoint)
• English and French language to professional working level.

This is an exciting opportunity if you are:

• Self-starter, autonomous, hands-on, pro-active, with can-do attitude.
• Low ego, collaborative, initiatives taking but not in isolation.
• High accountability, ownership, no “not-my-job”.

What Therapixel’s team expect from you:

• Thrive for excellence.
• Creative, curious, and ingenuous.
• Passionate.

Our working conditions….

• A convivial and flexible working environment, with a remote culture.
• Supportive environment (hiring, retaining, and promoting women is an integral part of our company’s culture).
• “People First” culture.
• A company culture based on autonomy & accountability
• Lunch card Swile, participation in your work-to-home travel expenses, sport membership participation, 100% coverage of the health insurance for you and your family.
• Annual company seminars to discover beautiful places and make strong connections.
• Offsites, after-work drinks, celebration of our success to recharge, have some fun and build shared memories and a strong team.
• International working environnement
• Location: Hybrid : our Paris office + remote
• Salary: 65-80K€, depending on experience
• Contract: permanent

Here are the stages in our recruitment process:

• Discussions about your driving forces, your ambitions and our mindset
• Technical tests
• Discussions with one or more members of the team, including your future manager
• Discussions with our CEO or Chief People Officer

Our recruitment process is mainly conducted by videoconference.

We are an equal opportunity employer and are committed to creating a diverse and inclusive workplace. We are proud to foster a workplace free from discrimination. We encourage all qualified individuals to apply.