10 March 2023
Regulatory Affair Specialist - Medical Devices || Italy
We are looking for a Regulatory Affair Specialist that 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.
As an equal opportunity employer, we welcome and consider applications from all qualified candidates, regardless of their background.
The ideal candidate will be responsible to:
- Ensures the execution of all regulatory activities related to the development of new products and for the improvement of existing ones.
- Ensures the implementation of the regulatory strategy for obtaining authorizations and manages regulatory issues relating to the products.
- 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.
- Collaborates in the preparation of the risk analysis of the products in accordance with ISO 14971.
- Provides support to departments that need advice on regulatory issues.
Master’s degree is preferred.
Certified participation to courses on Regulatory Affair is a plus.
- Significant knowledge of the European regulation on medical devices (MDR 2017/745)
- Significant knowledge of ISO 13485 and technical regulations for medical devices.
- Excellent knowledge of:
- WEB navigation
- Excellent digital competencies in:
- Information and data literacy
- Communication and collaboration
- Digital content creation
- Problem solving
Excellent knowledge of Italian and English is required.
At least one years in a similar position, preferably in the sector of medical devices.
Onsite at Albano Laziale (Rome) - Italy
COSMED is a worldwide leader in the design, development, manufacture and support of advanced diagnostic equipment and software. Our products are used in hospital, primary care, sports science, research and other medical and wellness environments to support a diverse, global, investigative requirement for infant, paediatric and adult testing. Whether testing an athlete, a pulmonary patient, a ventilator-dependent patient or an infant, COSMED products and solutions provide highly accurate data quickly and effectively.
COSMED respects your privacy and will treat your personal information as confidential.
We will use and share your personal information as described in our Privacy Statement.
NOTE: The above statements are intended to describe the general nature and level of work. Additional duties might be assigned. Management retains the right to add or change duties of the position at any time.