Medical Device Regulatory Affairs Assistant

il y a 7 jours

CagnessurMer, France DERMOSCIENCES Temps plein

**_About Dermaceutic_**

Dermaceutic is a dynamic and ambitious laboratory operating in the fast-growing sector of Aesthetic Dermatology, offering a wide range of professional and cosmeceutical products.

Over the last 15 years Dermaceutic has seen significant international growth and is now present in over 70 countries.

At Dermaceutic, we are a young, passionate, and international team working hard in a fast-paced environment. We encourage our employees to learn and grow within their roles, own their projects and be drivers of their own initiatives. Our core business values focus on innovation, efficacy, determination, anticipation, and a search for perfection across our product lines and best-in-class customer brand experience.

**_Mission_**

Within the Regulatory Affairs department, your mission will be to set up and prepare technical files related to medical devices.

**Project list : Constitution of technical files for medical devices**

1) Drafting and implementation of technical files according to the MDR (Medical Device Regulation)
- Write and compile technical files according to MDR 2017/745 medical device regulations.
- Participate in the update of the risk analysis of medical devices.
- Participate in product development and follow-up meetings with other departments (R&D, Sales and Marketing).
- Participate in the drafting of PMS (post market surveillance) reports
- Participate in the regulatory monitoring exercise (guides, technical standards)
- Contribute to the creation of an excel tool for the follow-up of technical documentation and annexes related to medical devices.
- Participate in the implementation or improvement of clinical monitoring of medical devices.

**_Qualifications_**
- Master's degree in regulatory affairs or health products or other degree in health engineering.
- Minimum 1 year experience in regulatory affairs or medical device quality.
- Knowledge of Microsoft Word, Excel, PDF.
- Written English is required. (Files to be written in English)
- Knowledge of Regulation 2017/745 is a plus.
- Juniors accepted.
- You are autonomous, organized and dynamic. You have a good project management, ease in managing documents, follow-up, and are a force of proposal.

**_Other information_**
- Remuneration : To be determined
- Start of contract : ASAP
- Location : Cagnes-sur-Mer
- Type of job : Fixed-term contract (6 months, eventually renewable)

Type d'emploi : Temps plein, CDD
Durée du contrat : 6 mois

Salaire : 20 147,40€ à 30 000,00€ par an

Avantages:

- Participation au Transport

Programmation:

- Du Lundi au Vendredi

Expérience:

- Affaires réglementaires: 1 an (Optionnel)

Langue:

- Anglais (Exigé)

Lieu du poste : Un seul lieu de travail

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