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Jr Quality Assurance and Regulatory Affairs Specialist - Paris

Société : DentalMonitoring
Lieu : Paris (Île-de-France)


Descriptif du poste

Société : DentalMonitoring
Catégorie : Stage
Filiere : IT/Etudes, développement et intégration
Lieu : Paris (Île-de-France)

Mission

DentalMonitoring is a MedTech scale-up in a fast-growing medical field. We are looking for new talent to join our team!

What is the added value of Dental Monitoring’s solutions for its clients

Our SAAS monitors and optimizes orthodontic treatment for doctors and patients alike using our app and patient platform

DentalMonitoring brings the first AI-driven technology in the oral healthcare space

With more than filed patents on our technology, we are leading an entire industry in how we approach the orthodontic experience

Our handy tool, the Scanbox, helps patients and doctors to easily detect intraoral observation

Their patients smile again

Dental Monitoring was promoted in the Next for the second year in a row.

This position is open to Juniors / entry level.

The Jr RA/QA Specialist Role

Participatesincommunication 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 and ISO and other future applicable quality (MDSAP) or regulatory requirements.
Leadstheuseinthecompanyofaqualitysystemsoftwaretoimprovetraceability, maintenance and avoid wasting time by an automatization of low added value actions
Reviews corporate quality KPI and prepare quality management reviews, including Oversight ofkeyqualityprocesses,including Internal/Externalaudit,SupplierQuality,CAPA,
Post-MarketSurveillance(Complaints,FieldAction),ChangeControl,Data& Documentation Management, Training and Product Release.
Defines the regulatory strategies in an unclear, still moving innovativefield: healthcare specific software and mobile applications. This includes a close collaboration with marketing, R&D and clinical departments to explain regulatory requirements.
Prepares and follows-up medical device registration applications for the targeted markets (registration applications, amendments...), such as CE countries, Australia, US, and others
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

The above is not an exhaustive list of all duties, responsibilities and qualifications associated with the job. Other duties may be assigned.

You will be successful in this role if you have

- years of experience in related area.

Engineering Degree or Pharmacist or MsC in Regulatory Affairs or Medical/Scientific field.

Ability to communicate effectively and build relationships with internal/external stakeholders.

Excellent organisation, rigour and analytical skills

Proficient in oral and written English

It would be fantastic if you have

Experience in a startup or scale-up environment

Knowledge in international regulation other than CE & USA regarding medical devices such as MDSAP

Other languages than French and English

Experience in the dental area

Our work environment

At Dental Monitoring our employees thrive because :

We are collaborators! It is a core value and our team of researchers, doctors, developers, salespeople and all of our stakeholders work together to put our customers first!

DentalMonitoring is a diverse, multicultural company: you can find more than nationalities throughout our teams

What we bring to our employees

Your ideas will be heard! Our culture promotes initiatives, ownership and feedback

Everyone is committed to supporting your professional development because we understand that no one can know everything

We place significant importance on the quality of work-life balance

Here are some perks that we offer our employees: Alan health insurance, Swile card, Free shares plan, Hybrid work, Gymlib, Corporate events, Referral policy


This role is Paris office based

DentalMonitoring is an equal opportunity employer and offers an intercultural and inclusive workplace. The diversity of our teams is one of our strengths. We work every day with more than nationalities in different countries all over the world. We welcome and encourage applications from people with disabilities. For those people we are committed to providing appropriate accommodation.


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