Quality & Regulatory Affairs

il y a 3 jours

Paris, France Implicity Temps plein

**Job Summary**
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 Caroline, your manager, and Yasmine, your legal colleague.

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.

**Your profile**

3 - 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.

2 - 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

1 - 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

Status: Cadre

Pay: 45,000.00€ - 55,000.00€ per year

Application Question(s):

- Quelles sont vos connaissances et votre expertise sur la norme ISO 13485 ?
- Quelles sont vos connaissances et votre expertise du règlement sur les dispositifs médicaux (2017/745) ?

Work Location: Hybrid remote in 75002 Paris

Expected Start Date: 10/11/2024

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