QA/ra Medical Device Consultant

1 settimana fa

Modena, Italia PQE Group A tempo pieno

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1200 employees, 45+ nationalities and 27 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means join a multicultural and challenging company in which you will be not only involved in international projects but you'll also have the chance to get in touch with colleagues from all over the world.

Due to a constant growth PQE is looking for a **QA/RA Medical Device Consultant** based in Modena Area, Italy who will be responsible for conducting QA and RA activities according to the required regulations.

**Responsibilities** include, but are not limited, to the followings:

- Support QA and RA activities at Medical Device Companies
- QMS procedures issue, review, update
- CAPA Process
- Risk Management
- Complaints Management
- Perform audits in Medical Device area
- Support Regulatory Affairs projects for Medical Device
- Support to CE marking
- Transition to MDR certification
- Support extra EU registration

**Requirements**:

- 3 years+ in Regulatory Affairs or Quality Assurance, in Medical Device industry
- Knowledge of: Medical Device requirements (ISO 13485, new MDR)
- EU and Extra EU MD registration processes
- Risk Management for Medical Devices
- Post market Surveillance
- V&V requirements
- English language fluency in speaking and writing
- Experience in global projects within the Life Science industry
**Location**: Modena (Italy)

Our collaborators are engaged, developed, challenged and well-rewarded for performance.

We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

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