Regulatory Affairs Officer

**Division**:GC Aesthetics

**Location**: Apt, France

**Job Title**:Regulatory Affairs Officer

**Department**: Affairs Regulatory

**Responsible to**:Regulatory Affairs Manager

**Purpose of Job (Summary)**

Ensure compliance with regulatory requirements for products manufactured and/or distributed by Eurosilicone, ensuring that the technical documentation complies with the applicable regulations. Enforce, as soon as possible, the registration, renewal, and/or modifications to the registration of products in the markets. Ensure the maintenance of documentation and databases of the activity Regulatory Affairs.

**Key Responsibilities**
- Design, manage and maintain technical files (new products / product modifications) with the applicable regulations and draw up the associated documents (reports, procedures, etc.). Follow the files according to the defined schedule.
- Ensure the updating of data / biological reports of Eurosilicone products.
- Ensure the updating of Post Market Surveillance (PMS) data / reports of Eurosilicone products.
- Participate in regulatory monitoring (research, gap analysis, monitoring of actions for compliance, etc.).
- Participate in the management and maintenance of the QMS documentation of the activity, non-conformities and CAPAs relating to the activity.
- Participate in the implementation of modifications
- Change Control new products / modifications products (input data, opening, monitoring, closing, reportability / impact assessment, etc.).
- Participate in the proofreading and validation of Marketing elements in relation to applicable regulations.
- Participate and assist during audits.
- Organize and follow the translation of the documents necessary for the activity.
- Support for the management and updating of the activity approval/certification database Regulatory Affairs (AX restrictions, certificates, FQF-042 forms, overview ).
- Support for compliance with applicable regulations, local and global, of labeling elements (IFU user manuals, labels, packaging, etc.).
- Assist the department on the activities of registrations, changes and / or renewals of Eurosilicone products, new products and/or products in new markets.
- Assist his hierarchy in updating the indicators / presentations of the Business process Regulations.
- Take charge of any other tasks / activities associated with the post

**Qualifications/Experience**
- Know the European regulations applicable to medical devices: directive 93/42, ISO 13845, ISO 14607, and the new Regulation (EU) 2017/745 relating to medical devices (MDR).
- Master computer tools such as office software (Word, Excel, Powerpoint), Internet...
- Master the current oral and written practice of the English language.
- Know how to collect, use and analyze data from a variety of sources.
- Know how to organize your work and have a sense of priorities to manage diversified activities in a optimal. Have the ability to work with precision, rigor and method.
- Have a sense of ethics and team spirit. Possess the communication skills to maintain constructive and partnership relations with all of the company's departments.
- Know how to establish and maintain regular contacts and partnerships with distributors, RA agents and authorities concerned to facilitate the progress of the files.
- Be able to mobilize to raise awareness on issues related to regulatory affairs