QHSE-REG Specialist

QHSE-REG Specialist (6-month Stage)

We are looking for a QHSE-REG Specialist that will be responsible to carry out all the activities necessary to:

• place and maintain on the market, the medical devices marketed by COSMED according to the laws, regulations and procedures of Italy, the EU, and of foreign countries where the company exports

• ensure the maintenance of the company's Integrated Management System (SG QHSE) in accordance with the requirements of Quality Assurance standards (ISO 9001, ISO 13485), Occupational Health and Safety (ISO 45001), and Environmental (ISO 14001) standards, as well as other mandatory and voluntary requirements in these areas

As an equal opportunity employer, we welcome and consider applications from all qualified candidates, regardless of their background.

TASKS

• Provides support in requesting certifications with relevant Italian, EU, or non-EU bodies, directly or by providing support to Business Partners.

• Provides support in drafting and maintaining technical files of the products required for the certifications.

• Collaborates with other departments to create reports of compliance with process or product standards.

• Provides support to departments that need advice on regulatory issues.

• Provides support in drafting and reviewing manuals, general procedures, operational instructions, and technical standards of the company's management system (SG QHSE) and compile QHSE registration documents relevant to the organizational unit.

• Participate in the review of business processes and activities with a view to improving efficiency and ensuring compliance with reference standards.

• Participate in the processes of managing deviations, non-conformities, and complaints.

• Participate in the initial evaluation process of suppliers and their qualification.

• Participate in the planning and execution of internal audits.

STUDIES

Master’s scientific degree.

TECHNICAL SKILLS

Excellent knowledge of:

• Office

• WEB navigation

KNOWLEDGE OF THE FOLLOWING TOPICS (considered a plus):

• European regulation on medical devices (MDR 2017/745)

• ISO 13485 and ISO 9001

• ISO 45001 and ISO 14001

LANGUAGE SKILLS

Excellent knowledge of Italian and English is required.

CONTRACT TYPE

6 months stage

WORKPLACE

Onsite in Albano Laziale (Rome) – Italy