QAra & Legal Assistant

**About Us**:
Implicity is a digital MedTech company bringing exceptional innovations to cardiologists through Big Data and Artificial Intelligence.

Our leading cardiac remote monitoring platform significantly simplifies data management and predicts patient issues, enabling cardiologists to deliver the best care at the optimal time. Simply put, by joining Implicity, you will contribute to saving lives with us.

Dr. Arnaud Rosier (cardiologist and AI researcher) and David Perlmutter (engineer and entrepreneur) co-founded Implicity in 2016.

Over 10 years later, a French Start-Up / Scale-Up is truly revolutionizing the healthcare market, literally shaping the future of cardiology. More than 250 hospitals / medical centers already use our solutions, covering over 100,000 patients.

At Implicity, you'll find leading experts in data science, engineering, clinical, regulatory, IT, sales, customer success, and more, working collaboratively. This incredible team has already made Implicity the undisputed European leader, and we will soon achieve the same in the US market.

**In summary, thanks to Implicity**:

- Patients receive significantly better care.
- Doctors' lives are much easier, allowing them to focus on prevention/treatment rather than administrative/data burden.
- Healthcare payers (Social Security in France) ultimately pay a much lower cost (prevention/monitoring instead of treatment/hospitalization).

**Your missions**:
You will:

- Assist in the maintenance and implementation of our quality management system (QMS) for product development in compliance with ISO 13485, IEC 62304, ISO 14971, FDA Title 21 CFR Part 11&820, Annex 11, GDPR, and GxPs.
- Assist in the Documentation Control Process and Documentation Change Control Process.
- Assist in the collection of the quality KPIs and metrics.
- Coordinate the onboarding of the newcomers in our QMS and keep track of their progress.
- Provide support in the preparation and documentation of internal and external audits of the QMS.
- Assist in the evaluation and progress of the changes in our QMS and the preparation of the corresponding corrective and preventive actions (CAPA), including the generation and review of CAPA files.
- Collaborate and attend internal follow-ups with the different teams (Engineering, HR, Customer Service, and MIR).
- Assist the generation and maintenance of records to comply with data protection regulations (GDPR, HIPAA) and security standards (ISO 27001, etc.)
- Assist in the preparation of the Management Review Meetings.
- Keeping traceability (revision, dates, audit trails, etc) of the documentation from the different development teams according to our QMS.
- Maintain all HR-related records/evidence within our QMS in collaboration with the HR team (onboarding, continuous training, Job Descriptions, and Organizational Chart, among others).
- Assist with premarket FDA, CE, and international regulatory submissions.
- Assist in literature review

At Implicity, you will have a weekly meeting with your manager, to help you succeed in your mission, and continuously improve your skills.

Each team works with quarterly OKR, to be crystal clear, fair and honest with your targets.

The annual appraisal is a shared exchange moment, focused on your development.

**Your profile**:
To be considered for this position, the following skills have to be obvious on your education / experiences:

- Bachelor (Medical Device, Biomedical or equivalent)
- You have at least 2 years’ experience
- You know of the ISO 13485 (professional experience)
- You have experience with RGPD & DPO topics

In addition, here are some important basics to succeed in this position:

- Previous experience in Quality and/or Regulatory (2 years at least)
- You are self-driven and definitely able to multi-task
- You are fluent in French & English (spoken & written)
- You have a strong bias for action, and get things done, even if you don’t fully understand everything
- You have Strong interest in the innovation and health ecosystem
- You are IT agile (we use Notion, Slack, Drive, etc.) as daily tools

The bonus skills that would definitely make us pick you:

- You know the FDA regulation
- You enjoy working in a fast-paced and ever-changing environment
- Strong work ethic & daily act with integrity, honesty and fairness
- Definitely a thoughtful team player, looking to make your colleagues successful
- You like this ad, and think this is very like you

**Recruitment process**:

- 30min screen call (phone or video)
- Interview with the team (QARA + Legal)
- Last interview with Arnaud (CEO) or Lucie (COO)
- Ref call

Type d'emploi : CDD
Durée du contrat : 6-12 mois

Rémunération : 30 000,00€ à 32 000,00€ par an

Horaires:

- Du lundi au vendredi
- Travail en journée

Lieu du poste : Télétravail hybride (75002 Paris)

Date de début prévue : 05/05/2025