⭐️ We need you ⭐️

Reporting to Caroline, our Head of Quality and Regulatory Affairs, working closely with the rest of the team (QARA and Legal), your job is to help and smoothen all related to Quality, Regulatory and Legal subjects.

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.

⭐️ You are ⭐️

🥉 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 😊

It is OK to apply without meeting all the criteria: just honestly tell us why you think you can be THE one.

😁 More cool stuff to know about Implicity 😁

💰 Remuneration

• For this job (CDD - full time), your base salary will be 30-32k€ depending on your experience

👍 Benefits

• Health care plan: Alan (40,5€ / month + 21€/month for kids) 

• Luncheon voucher: 9€ (50% employer)

• Transport: 50% of your pass  OR  sustainable mobility pass

✅ Why us?

Simply because you will get all Scale-Up advantages without the usual drawbacks!

• Activity: we are a “purpose company” - that really drives everyone’s daily motivation and commitment 

• Solution: we built a best-in-class solution, that has no direct competitor 

• Growth stage: we are not small - we are not big - we are 70  =>  our boom is to come

• International: we operate at a global level, and our working language is English

• Values: we do have values, and these are not just for posters!

      . Integrity: we act with honesty and fairness

      . Ambition: we strive for excellence in a healthcare demanding environment 

      . Cooperation: we care, we support, we seek collective success

• Autonomy: you’ll definitely get real responsibilities, and have the chance to have impact 

• Employee care:

      . Our beautiful office is “rue du Louvre” (between Chatelet & Bourse) 

      . Regular team events, especially every Thursday evenings

• Tools: we used Slack, Notion and Drive, and it is pretty cool

• Remote: up to 3 days / week 

• Worklife balance: we are definitely respectful 

• Shareholder: you will be incentivized with company equity

Do you need more arguments? We’ve got a bunch!

🤓 Want more infos?!

• Our website: https://www.implicity.com/about-us/

• Our team: https://www.welcometothejungle.com/fr/companies/implicity/team

• Our other opening jobs: https://www.implicity.com/careers/

• Our cool grade on Glassdoor: https://www.glassdoor.fr/Pr%C3%A9sentation/Travailler-chez-Implicity-EI_IE4010545.16,25.htm

• Our $23M Series A last January 2022: https://www.implicity.com/ressource/seriesa/ 

• A cool article by La Tribune: https://www.latribune.fr/technos-medias/innovation-et-start-up/la-startup-de-la-semaine-implicity-previent-les-crises-cardiaques-grace-aux-donnees-829691.html

• And finally, 2 interviews of our CEO Arnaud Rosier:

. https://www.youtube.com/watch?v=1ofIQQMWqZo

. https://www.bsmart.fr/video/1727,37-ecosysteme-implicity

🙏 Let’s meet

• If you believe that you are the right person for Implicity, we are looking forward to receiving your application through the Implicity page on “Welcome To The Jungle” website

• We are proud to be an equal opportunity employer. We constantly challenge ourselves to build a diverse team of talents and to create an inclusive environment for all employees

• Recruitment process:

1°   30min screen call (phone or video)

2°  Interview with the team (QARA + Legal)

3°  Last interview with Arnaud (CEO) or Lucie (COO)

4° Ref call

\=> Depending on your availability, the recruitment process should last less than a mont.

Offer usually follows within 72 hours 🤞