Ra/qa Specialist

Dental Monitoring is a MedTech Scale-up experiencing tremendous growth. We are looking for new talents to integrate our team

Dental Monitoring in a few words?
- A solution at the cutting edge of artificial intelligence and image analysis in the dental field, enabling remote support for patients and practitioners.
- A Tech company in full growth, always looking for innovation, quality and performance.
- An international team with a friendly and benevolent spirit, focused on the same objective: to offer the most adapted and qualitative solutions possible.
- The first unicorn of the dental sector

We are currently looking for a **RA/QA Specialist** to support our growth.

**Roles and responsibilities**
- Participates in communication inside and outside the company to educate your Dental Monitoring colleagues and clients regarding quality & regulatory requests.
- Ensures that the quality system is maintained or updated in compliance with ISO 13485 and ISO 27001 and other future applicable quality (MDSAP) or regulatory requirements.
- Leads the use in the company of a quality system software to improve traceability, maintenance and avoid wasting time by an automatization of low added value actions
- Reviews corporate quality KPI and prepare quality management reviews, including Oversight of key quality processes, including Internal/External audit, Supplier Quality, CAPA, Post-Market Surveillance (Complaints, Holds, Field Action), Change Control, Data & DocumentationManagement, Training and Product Release.
- Maintains registrations after the product is placed on the market.
- Ensures communication with competent authorities.
- Defines the labelling and check promotional material
- Ensures the needed regulatory & quality assurance watch

Information Security
- Be aware of their own responsibility regarding information security
- Perform their work according to the applicable policies and procedures
- Contribute actively to the continuous improvement of our ISMS
- Report any observed or suspected weaknesses in our ISMSand any information security incident

**Essential Qualifications**
- Engineering Degree or Pharmacist or MsC in Regulatory Affairs or Medical/Scientific field.
- Good knowledge of quality and regulatory environment: ISO 13485, ISO 14971, MDSAP, MDR 17/745, IEC 62304
- Normative knowledge of active medical devices and software.
- Excellent organization and communication skills.
- Rigor and analytical skills.
- Ability to communicate effectively and build relationships with internal/external stakeholders.
- Strong team spirit.
- Proficient in oral and written English

**Preferred Qualifications**
- Knowledge in FDA and other international regulation
- Other languages than French and English
- Knowledge in coding/development
- Experience in the dental area

**Your working environment**

DM is a great place to work, and as a **RA/QA Specialist** here you will thrive because:

- Your ideas will be heard Our culture promotes initiatives and ownership and we recognize gumption.
- Everyone will do their best to help you develop your skills -we know you can’t know everything.
- Huge potential for collaboration: researchers, doctors, customer lovers (customer success managers), business developers, trainers, data analysts, testers, regulatory angels, teams of developers and of course customers
- At our headquarters in Paris, we have a lot of languages and cultures and this is awesome, chouette, geil, fantástico, perfetto, geweldig and even 很酷.

**Dental Monitoring is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.