Design Control Specialist - Medical Devices Milano

Design Control Specialist - Medical Devices
Milano
Lombardia, Milano

Our client, **Chiesi Farmaceutici **- one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of **Design Control Specialist - Medical Devices - **who can join an exciting working environment in a dynamic and international atmosphere.

**JOB DESCRIPTION**:

The scope of the role is to support the generation, maintaining and archiving of design control documentation in relation to design and development of Drug Delivery Devices or Medical Devices.

**RESPONSIBILITIES**:

- Support for the generation, review and update of Design Controls Documentation for Drug Delivery Devices or Medical Devices in compliance with the applicable regulatory requirements.

- Support for the generation of technical documentation for the design and development of Drug Delivery Devices or Medical Devices.

- Support of activities of Risk Assessment and preparation and archiving of Risk management file.

- Support to the classification and archiving of technical documentation for the design and development of Drug Delivery Devices or Medical Devices.

- Support in the management of documents relating to the GTD -DEV DEV department in the corporate document system.

- Support to the generation, review and update of SOP and WI in the field of Design Control o Device development.

- Actively participate to work programs with a cross-functional team.

- Support to the planning, preparation and execution of Design Review.

- Support the generation, maintenance and updating of the Design History File Index.

- Support the generation, maintenance and updating of the Device Master File Index.

- Support for the redaction of supportive documentation for the preparation of relevant section of device contents for Technical Dossier, Technical documentation, IMPD, IND, etc for Regulatory purpose.

**REQUIREMENTS**:

- Degree in scientific or technical discipline

- At least 2/3 years of experience in Pharmaceutical or Medical Device companies in the role of Documentation specialist or Quality Assurance / RA Assistant or Design Control specialist.

- Knowledge of Medical Device Regulation, ISO 13485, FDA 21 CFR 820 and 21CFR part 4.

- Precision and accuracy

- Ability in Technical and QA Document redaction

- Quality of written communication, Document redaction, Delivering presentations,

- Ability to work in team

- Time Management, Prioritisation

- English knowledge

**TYPE OF CONTRACT**:

Permanent contract

Chemical contract