Implicity
Implicity

Quality & Regulatory Affairs Manager

Permanent contract
Paris
Salary: €60K to 70K
A few days at home
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Implicity
Implicity

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Questions and answers about the job

The position

Job description

  • Job and recruitment context
  • Joining the regulatory team, reporting to Head of Quality and Regulatory Affairs, your mission is to maintain the Quality Management System, with the objective of improving and automating processes
  • Your simply are the Quality Lead of Implicity
  • You then manage the roadmap and implement your plan regarding our ISO 13485 certification
  • You also run risk analysis (ISO 14971)
  • You provide relevant feedbacks on all matters / documents / processes you recommend to improve
  • You also work on technical reports for all target countries (US, Europe, Canada)
  • You work with our Clinical deparment to ensure everything is running as expected
  • You are in charge of the regulatory watch
  • To succeed in your mission, you will be helped by your team : Caroline, Yasmine, Siham and Megane.
  • At Implicity, you will have a weekly meeting with your manager, to help you succeed in your mission, and continuously improve you skills.
    Each team works with quarterly OKR, to be crystal clear, fair and honest with your targets.
    The annual appraisal is a dedicated exchange moment, focused on your development.

🥉 To be considered for this position, the following skills have to be obvious on your education / experiences:
Master degree (Scientific, Biomedical Engineer or equivalent) with a specialization in Regulatory Affairs (UTC, ISIFC, etc.)
You know of the ISO 13485 (school or professional experience)
You know the Medical Device Regulation (2017/745)
You speak fluently French & English
You have a strong work ethic & daily act with integrity, honesty and fairness
You are definitely a thoughtful team player, looking to make your colleagues successful.

🥈 In addition, here are some important basics to succeed in this position:
Previous experience in Quality and/or Regulatory
You are self-driven and definitely able to multi-task
You have writing skills (both in French & English)
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 Notions, Slack, Drive, etc.) as daily tools

🥇 The bonus skills that would definitely make us pick you:
You know the FDA regulation
You have writing skills (both in French & English)
Low-ego & High-energy, you are definitely resilient
You are a Do-er / pb-solver, enjoy overcoming barriers and helping the team to win
You like this ad, and think this is very like you 😊

It is OK to apply without meeting all the 2nd and 3nd paragraph skills: just honestly tell us why you think you can be THE one.


  • Recruitment process 
  • 1. HR Interview (30min) 
  • 2. Manager Interview (60min) 
  • 3. Cross-team interview (60min)
  • 4. Final Interview (60min) 
  • 5. Reference check
  • 6. Job Offer (usually follows within 72 hours 🤞) 
  • Depending on your availability, the recruitment process should last less than 3-4 weeks

General information

💰 Salary

  • For this job (type of contract), you have a base salary (60-70k€) depending on your experience
  • Company equity (BSPCE)

👍 Benefits

  • Health care plan: Alan (35€ / month + 20,25€/month for kids)
  • Luncheon voucher: 9€ (50% employer)
  • Transport: 50% of your pass OR sustainable mobility pass

📍 Remote work & Location

  • 3 days per week (progressively)
  • Location: 29 rue du Louvre, 75002, PARIS

    ✅ 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
    • Worklife balance: we are definitely respectful & remote friendly 
    • Shareholder: you will be incentivized with company equity

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