Registration and PMS Specialist

Client

Serendip Consulting est un cabinet de recrutement de cadres par approche directe et de conseil en Ressources Humaines spécialisé dans le domaine de la santé.

Notre client est une entreprise française leader sur le marché de la stérilisation au plasma froid. Elle intervient dans le domaine de stérilisation et permet grâce à sa technologie innovante la sécurisation du traitement des patients et propose une solution unique soutenable de stérilisation.

Afin de renforcer ses équipes, il recrute un(e) :

Registration and PMS Specialist H/F

Poste

Rattaché(e) au Directeur des affaires règlementaires, vous aurez la responsabilité sur ces différents domaines :

1. Registration
- Participate in the creation and filing of regulatory files (510k, De Novo, etc.);

- Manages the registration of the company and the products in all countries (creation and maintenance of registration files, exchange with the Competent Authorities and the company's distributors, filling in the databases like EUDAMED and GUDID, etc.).


2. Clinical affairs and PMS
- Manages clinical evaluation files (carrying out research and critical analysis of the literature, demonstration of equivalence, writing the clinical evaluation plan and report, etc.);

- Manages clinical investigations (participation in the drafting of protocols, contact with the investigation center, follow-up of actions, etc.);

- Manage post-market surveillance (drafting of post-market surveillance plans, data collection and analysis, writing of trend reports, PSUR and PMS reports, etc.);

- Manage post-market clinical follow-up (drafting of post-marketing clinical follow-up plans, collection and analysis of clinical data, writing of PMCF reports, etc.);

- Participates in complaints and vigilance management (drafting of vigilance related QMS records, participation in analysis, participation in the drafting of Field Safety Notices, follow-up of action plans, etc.);


3. Other tasks
- Responsible of the regulatory and normative oversight (identifies new standards and requirements, makes sure the list of a Regulations and standards follow-up is up to date, performs gap analysis, write the regulatory and normative newsletter, …);

- Can participate in the writing of the Technical Files of the medical devices (Device description, Risk Management File, biological evaluation file, general safety and performance requirements, list of applicable standards, etc.);

- Can participate in the maintenance and continuous improvement of the company's Quality Management System (drafting of procedures, instructions, templates, etc.);

- Can participate in staff training and awareness (especially on regulatory and clinical requirements);

- Can provide support to the Sales & Marketing Department for the review and approval of allegations on promotional materials;

- Is the deputy of the Person Responsible for Regulatory Compliance (PRRC, in accordance with the MDR 2017/745 article 15). He ensures that:
a) the post-market surveillance obligations are complied with in accordance with Article 10(10);
b) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Profil

Profil recherché :

Education level
- Engineering school specializing in the field of medical devices
- 3rd university cycle (Master) specialized in the field of medical devices, pharmaceuticals, or health regulations

Experience
- This position requires a minimum of 2 years’ experience in a similar position
- Experience in the field of sterilization would be appreciated

Technical skills
- Registration: MDSP, UKCA, Europe, …
- Clinical standards: MEDDEV 2.7/1 rev.4, MEDDEV 2.12/2, …
- Regulatory: RDM 2017/745, 21 CFR Part 803 & 806, …

Soft skills
- Writing skills, mastery of the Microsoft Office pack
- English level B2 or higher (CEFR)
- Autonomy
- Analytical and synthetical mind
- Organizational skills, meeting organization