Quality Assurance and Regulatory Affairs Director - H/F
Marseille
CLQARA – Quality /
CDI statut cadre /
Hybrid
đź«€Who are we ?
The creation of Volta Medical follows the discovery of a new complex medical procedure to treat atrial fibrillation (the most common cardiac arrhythmia in the world) by the company’s founders, world experts in interventional rhythmology and intracardiac signal analysis.
Volta Medical is an innovative start-up based in Marseille, whose goal is to provide a range of artificial intelligence-based products to guide the cardiologist during ablation-type procedures.
We started this adventure 7 years ago and our team now has more than 100 employees in France, Germany and the United States ! We completed a $27 million Series A round in November 2020 and a $36 million Series B round in January 2023.
đź«€Our values
- Be a pioneer: Be brave. Don’t be scared of researching, exploring, trying and sometimes failing.
- Improve patients’ lives: Create products to provide electrophysiologists with the best user-experience possible, to help them improve the lives of patients.
- Strive for excellence: Push yourselves to deliver the highest quality in everything you do. Learn from your mistakes and aim for the best.
- Collaborate as a team: Welcome to a multidisciplinary and a diversified team ! Try to understand people from different cultures and environments. Confront your ideas and have fun !
đź«€Missions
- As a key member of the Clinical, Quality and Regulatory Affairs department, you will coordinate the quality and regulatory affairs team and be responsible for implementing the company's quality objectives and processes, ensuring overall consistency between the various departments, and ensuring that the regulatory strategy for the various products is properly implemented.
- Define quality policy and propose it to the leadership team,
- Promote quality within the company,
- Oversee the definition of methodologies, tools and indicators used to periodically assess the quality system and monitor compliance of quality system processes,
- Ensure the conformity of manufactured products and contribute to the control of production processes, in particular by defining production control activities,
- Supervise the management of non-conformities and corrective/preventive actions,
- Plan and control the implementation of various audits (internal, external, subcontractors),
- Manage QARA human resources (4 people) and budget,
- Manage professional relations and communication with certifying bodies and authorities,
- Co-lead the company's regulatory strategy,
- Guide and supervise regulatory activities to ensure that products comply with regulations,
- Participate in the development, review and approval of technical documentation as part of product design and development.
Reporting to the SVP Clinical, Quality & Regulatory Affairs, the QARA Director will be responsible for:
đź«€Profile
- You have an engineering degree or Master's in Regulatory Affairs/Quality Assurance in Medical Devices,
- You have at least 8 years' experience in Regulatory Affairs/Quality Assurance in an active medical device company (hardware/software),
- You are fluent in English (daily written and oral exchanges),
- You are fully proficient with ISO 13485, 21 CFR 820, Regulation (EU) 2017/745, and other medical devices standards (ISO 14971, IEC 62366, IEC 60601…),
- You have auditor certification and/or significant experience in internal/external audits,
- You have experience in team management,
- You have good communication skills and diplomacy,You are a mediator and facilitator, with charisma and leadership skills,
- You have excellent analytical and writing skills,
- You are rigorous and methodical.
đź«€What we can offer you at Volta Medical
- A pleasant work environment, with ideally located offices in the 6th district of Marseille offering a beautiful view upon Notre Dame de la Garde and the Mediterranean Sea.
- The possibility of working from home 2 days a week
- Passionate colleagues that have the same goal in mind: improve patients’ lives
- A corporate culture based on innovation, empowerment and collaboration.
- An international environment that allows you to practice your best american accent
- Prospects of ambitious evolutions with various internal mobilities
- Regular team building events, breakfasts, and for the people enjoying sport activities, free weekly yoga classes
- And more traditional advantages: a lunch voucher card (Swile), a good health insurance (Malakoff Humanis), a vacation bonus, RTTs in addition to paid vacation, as well as exceptional days of absence on top of those provided in the collective agreement (compensation hold in case of illness starting from 6 months of seniority, additional days for a sick child, moving leave, etc.)Join a company on a human scale, whose operations leave room for initiative and innovation in the service of patients.
đź«€Recruitment process
- Interview with the SVP Clinical, Quality & Regulatory Affairs
- Technical test/Situational setting
- Reference Check
- Culture fit interview with the Global VP People and a Volta ambassador
€60,000 - €70,000 a year
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The information provided is for the use of Volta Medical’s recruitment team as well as other recipients (individuals and organizations) involved in the recruitment for the position that you applied for. Your information will be stored for the duration of the processing of your application. If you are not selected for the position, your information will not be stored, unless you consented to being included in our applicant database. In this case, your information will be stored for 2 years from the date of the submission of your application to enable us to contact you for future opportunities. Nevertheless, you have the right to withdraw your consent at any time.
As part of its activities, Volta Medical may transfer data to a country outside of the European Union with appropriate safeguards in place.
Volta Medical’s Privacy Policy provides more in-depth details about how your information is used and stored, as well as the legal bases that dictate the information processing that is carried out. The Privacy Policy also includes a reminder of your personal data rights and information on how to reach us with any questions or concerns.
