Regulatory Affair Officer

1 giorno fa

Monza, Italia Viatris A tempo pieno

9145 Meda Pharma S.p.A.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the RA Officer role will make an impact:
Key responsibilities for this role include:

- Fulfill RA requirements according to the current European legislation and/or to the relevant country legislation to guarantee business continuity
- Prepare and update the technical documentation for new registrations and for the validity maintenance, through variations and/or renewals, of exiting certifications and authorizations
- Follow-up with the countries the RA activities for new registrations, variations and renewals and the release of authorizations for Medical Devices and In-Vitro Diagnostics worldwide
- Cooperate to product International and Country Masters texts definition/update for the finalization of the packaging material worldwide
- Cooperate with different Company functions for a continuous verification of regulatory compliance
- Prepare the Master Technical File for all classes of MDs and for IVDs and to collect/assemble the whole documentation
- Prepare response documents to the questions of Notified Bodies arisen during new certification/variation processes of MDs or IVDs and make the technical documentation compliant to the Notified Bodies’ requests
- Update Master Technical Files annually aimed to maintain the CE-marking and the conformity of the products to the current EU legislation
- Participate to R&D activities on MDs and IVDs (e.g. verify MDs or IVDs essential requirements vs. the harmonized standards during the development phase)

The minimum qualifications for this role are:

- Bachelor degree or higher in science or health related field (Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Biological Sciences are preferred)
- Good knowledge of Windows and Microsoft Office
- A fixed term contract is offered due to a maternity leave replacement

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

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