International Regulatory Affairs Officer Monza

International Regulatory Affairs Officer
Monza
Lombardia, Monza

Nata più di cento anni fa come cooperativa di farmacisti, Cooper Consumer Health è oggi la più grande organizzazione indipendente di selfcare in Europa offrendo soluzioni efficaci, sicure e convenienti per il benessere quotidiano. La nostra missione è rendere la salute accessibile a tutti, aiutare le persone a prendersi cura della propria salute in modo autonomo, offrendo soluzioni efficaci e accessibili. Grazie a un portfolio di marchi leader come Betadine, Duphalac, Armolipid, Audispray, Excilor e molti altri, oltre 80. 000 farmacisti consigliano ogni giorno i nostri prodotti.

Crediamo nella consapevolezza e nell'empowerment: vogliamo fornire alle persone le conoscenze e gli strumenti per prendere decisioni informate sulla propria salute.

We are looking for an International Regulatory Affairs Officer to join our RD Centre of Excellence in Monza with expertise in cosmetics, medical devices and food supplements.

The role is an individual contributor on Medical Devices.

He / She obtains and maintains EC certifications and registrations of MDs and IVDs under the supervision of the GPPS - RA Manager. KEY RESPONSIBILITIES 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 MDs and IVDs worldwide. Participate 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 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 Technical Files aimed to maintain the CE-marking and the conformity of the products to the requirements of the current EU legislation. Participate to RD activities on MDs and IVDs (e. g.

verify MDs or IVDs requirements vs. the harmonized standards during the development phase). QUALIFICATIONS Bachelor's Degree or equivalent in Scientific Disciplines (Chemistry and Pharmaceutical Technology, Chemistry, Industrial Chemistry, Pharmacy, Biology, Biotechnology) is required.

Master's degree or equivalent in Regulatory Affairs is preferred.

Post graduate qualification in a science discipline or work related to the position would be an advantage.

EXPERIENCEMinimum 3 years in Pharma Industry and 3 years of former experience in the same position in the Pharmaceutical or Medical Devices Industry.

A former experience for position as a Global RA in the Pharmaceutical or Medical Devices Industry.

Discipline expert, typically with a number of years post qualification experience or equivalent business experience.

Problems may require complex analytical or problem-solving techniques to define and identify cause.

Requires evaluation, interpretation, and judgment to select the right course of action which may or may not be defined.

Interprets or explains data or information to deliver messages to audiences not knowledgeable about the subject matter.

Contributes to the achievement of short-term functional goals through personal effort or influence over other team members and may affect related activities in other functions.

Accountable for planning the details of own work assignments. You must possess precision, proactivity, flexibility, organizational skills and an aptitude for teamwork. PLACE OF WORK: Via Valosa di Sopra n. 9 – Monza (MB)La ricerca è rivolta a persone di entrambi i sessi (D. lgs.

n. 198/2006) e nel rispetto di quanto disposto dall'art.

10 del D. lgs.

n. 276/2003.

"Ai sensi degli Artt. 13 e 23 del Decreto Legislativo 196/2003 si richiede espresso consenso al trattamento dei dati personali.