We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1500 employees, 45+ nationalities and 30 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE Group means being a part of a multicultural and challenging company, with many local and international projects and colleagues from all over the world.
Due to a constant growth, PQE Group is looking for a Junior Regulatory Affairs – Medical Devices Consultant who will support our clients based in Mirandola, Italy.
Joining PQE will give you the opportunity to acquire the following professional competencies:
- Participation in maintaining the product technical documentation to be submitted to Notified Bodies/Competent Authorities for approvals;
- Collect and organize documents needed for medical device registrations with Competent Authorities;
- Conduct periodic verification of the applicable regulatory requirements in the involved jurisdictions to identify new/revised applicable external origin documents/requirements;
- Assists in updating product technical documentation in order to meet new applicable regulatory requirements;
- Assists in implementing and maintaining a quality system that is compliant with ISO 13485 and with quality system regulation requirements;
- Participation in the Post Market and Vigilance process;
- Participation in notifying Competent Authorities/Notified Bodies upon occurred incidents/reportable events;
- Interact with Competent Authorities/Regulatory Representatives/Notified Bodies upon requested documents/information for marketing approvals maintenance.
- Technical Degree (Biomedical Engineering, Chemistry, Biology, Physics, Mathematics)
- Full availability to Travel up to 75%
- English language fluency in speaking and writing (at least B2/C1)
- Availability for body rental activities (from 1 to 3 years of on-site permanence by our clients’sites)
Location: Mirandola, 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.