Post-Market Surveillance and Complaints Specialist – H/F
Marseille
CLQARA – Regulatory Affairs /
CDI statut cadre /
Hybrid
🫀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 8 years ago and our team now has more than 120 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.
🫀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 !
🫀Missions
- We are seeking a dedicated Post-Market Surveillance and Complaints Specialist to join our Clinical, Quality and Regulatory Affairs team. The ideal candidate will be responsible for managing customer complaints, coordinating post-market surveillance activities, and supporting regulatory compliance efforts. This role requires a proactive individual with strong analytical skills and the ability to work collaboratively across various departments.
- Translate event reporting forms into customer complaint records.
- Perform initial assessments of the need for event reporting, under the supervision of the vigilance correspondent.
- Lead the follow-up of complaint investigations, ensuring timely and effective resolution.
- Coordinate the customer complaints committee, managing investigation processes and related non-conformities follow-up.
- Prepare customer letters in response to complaints, ensuring clear communication and resolution.
- Train field teams on customer complaint reporting procedures to ensure compliance and consistency.
- Coordinate PMS activities, including the development and execution of PMS plans, reports, and Periodic Safety Update Reports (PSURs).
- Contribute to product risk analysis and usability engineering files within the scope of PMS activities to enhance product safety and effectiveness.
- Participate in the development and implementation of regulatory Standard Operating Procedures (SOPs), instructions, and forms to maintain compliance with industry standards.
- Assist in internal and external audits as required, providing necessary documentation and support.
- Collaborate cross-functionally with Clinical, Quality, and Regulatory Affairs colleagues to support comprehensive regulatory compliance and quality assurance efforts.
Your main responsibilities will include:
Customer Complaints Handling
Post-Market Surveillance
General Responsibilities
🫀Profile
- You have a Master’s or Engineering degree in a relevant field (Life Sciences, Engineering, Quality Assurance).
- You have 3 years of experience in Quality Assurance and/or Regulatory Affairs.
- You have experience in handling customer complaints and post-market surveillance in the medical device industry.
- You have knowledge of medical device regulations and standards.
- You possess excellent analytical and problem-solving skills.
- You have effective communication skills, both written and verbal.
- You have the ability to work independently and as part of a team.
- You are detail-oriented with a strong commitment to quality and compliance
- You are fluent both French and English
🫀What we can offer you at Volta Medical
- A pleasant work environment, with ideally located offices in the 6th district of Marseille offering a magnificent 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 for gourmands 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.
🫀Recruitment process
- Phone Interview with our Talent Acquisition Specialist (30’)
- Interview with our Regulatory Affairs Team Leader (60’)
- Interview with our Quality Assurance & Regulatory Affairs Director (60’)
- Culture Fit interview with our Global VP People and Volta Ambassador (60’)
€40,000 - €45,000 a year
The information that you provide is subject to personal data processing by Volta Medical as data controller for the purpose of managing your job application.
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.
