Regulatory Affairs Manager

2 settimane fa

Lazio, Italia Meditrial A tempo pieno

Industry: Lifescience Industry: Medtech, Digital Health

Employment Type: Full-time

Job Functions: Regulatory Affairs

Location: Meditrial, Via Po 9 Rome, Italy

Workplace: Office-based / availability to travel

The Regulatory Affairs Manager oversees the regulation process for products (Medical Device and Marketing Authorization) requiring governmental approval, including filing necessary applications and handling all government interactions. The position will ultimately support and/or drive strategic regulatory strategies for multiple projects together with the subject matter experts. Coordinates inspections of the organization and contract facilities, and develops procedures to ensure regulatory compliance pre and post-market.

Responsibilities

  • Collaborate during implementations of regulatory strategies for Medical Devices through National/Decentralized/Centralized Procedures
  • Collaborate during the Technical File (TF) creation and any updates
  • Support the management of clinical investigations, drafting and reviewing essential documentation including clinical investigation protocols
  • Manage the Medical Device Post-marketing and Surveillance Medical Devices activities
  • Supervise International Regulatory and Quality activities
  • In addition to the above activities, the role can be asked to carry out tasks related to the belonging function or that may result from business needs

Qualifications

Education: Master’s Degree in science or related field; Doctor of Medicine (MD) is a plus.

Thorough experience in life-science field and Regulatory Affairs.

Languages: Proficiency in oral and written English and Italian (third language is a plus).

Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, MS PowerPoint).

Excellent communication, planning, and organizational skills.

Demonstrated ability to handle multiple competing priorities.

#J-18808-Ljbffr

  • Regulatory Affairs Manager

    3 settimane fa

    Lazio, Italia Pqe Group A tempo pieno

    Sei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ?PQE Group è affermata in questo settore dal 1998 , garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti...

  • Regulatory Affairs Manager

    3 settimane fa

    Lazio, Italia Pqe Group A tempo pieno

    Sei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ?PQE Group è affermata in questo settore dal 1998 , garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti darà:...

  • Regulatory Affairs Manager

    3 settimane fa

    Lazio, Italia Pqe Group A tempo pieno

    Sei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ?PQE Group è affermata in questo settore dal 1998 , garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti darà:...

  • Regulatory Affairs Manager

    3 settimane fa

    Lazio, Italia Pqe Group A tempo pieno

    Sei pronto per entrare a far parte di unasocietà di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device?PQE Group è affermata in questo settore dal1998, garantendo una presenza internazionale grazie alle45 filialie i2000 dipendentiin Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti darà:La...

  • Regulatory Affairs Manager, Se

    3 settimane fa

    Lazio, Italia Colgate-Palmolive Company A tempo pieno

    No Relocation Assistance Offered Job Number #164255 - Roma, Lazio, Italy Who We Are Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition.Our products are trusted in more households than any other brand in the world, making us a...

  • Regulatory Affairs Manager

    2 settimane fa

    Lazio, Italia Meditrial A tempo pieno

    Industry: Lifescience Industry: Medtech, Digital Health Employment Type: Full-time Job Functions: Regulatory Affairs Location: Meditrial, Via Po 9 Rome, Italy Workplace: Office-based / availability to travel The Regulatory Affairs Manager oversees the regulation process for products (Medical Device and Marketing Authorization) requiring governmental...

  • Regulatory Affairs Manager

    3 settimane fa

    Lazio, Italia The Kraft Heinz Company A tempo pieno

    Job DescriptionWe have an exciting opportunity available for a Regulatory Affairs Manager in Italy.The position is based in Milan, where you will be working in an impactful team, alongside stakeholders that are always trying to reach the next level.You will be part of the Legal, Government and Regulatory Affairs department, reporting to the European...

  • Regulatory Affairs Officer

    3 settimane fa

    Lazio, Italia Productlife Group A tempo pieno

    Intexo, parte del Gruppo PLG, è alla ricerca di un/una Regulatory Affairs Officer con almeno due anni di esperienza nel ruolo, da inserire nella propria sede di Roma.Chi siamoIntexo Società Benefit, una realtà di consulenza del gruppo ProductLife, opera nel settore healthcare con l'obiettivo di garantire un accesso rapido, trasparente e sostenibile alle...

  • Regulatory Affairs Officer

    2 settimane fa

    Lazio, Italia Productlife Group A tempo pieno

    Intexo, parte del Gruppo PLG, è alla ricerca di un/una Regulatory Affairs Officer con almeno due anni di esperienza nel ruolo, da inserire nella propria sede di Roma.Chi siamo Intexo Società Benefit, una realtà di consulenza del gruppo ProductLife, opera nel settore healthcare con l'obiettivo di garantire un accesso rapido, trasparente e sostenibile alle...

  • Regulatory Affairs Manager

    3 settimane fa

    Lazio, Italia Jr Italy A tempo pieno

    Social network you want to login/join with: Job Description We have an exciting opportunity available for a Regulatory Affairs Manager in Italy. The position is based in Milan, where you will be working in an impactful team, alongside stakeholders that are always trying to reach the next level. You will be part of the Legal, Government and Regulatory Affairs...

  • Regulatory Affairs Manager

    3 settimane fa

    Lazio, Italia Jr Italy A tempo pieno

    Social network you want to login/join with: Job DescriptionWe have an exciting opportunity available for a Regulatory Affairs Manager in Italy.The position is based in Milan, where you will be working in an impactful team, alongside stakeholders that are always trying to reach the next level.You will be part of the Legal, Government and Regulatory Affairs...

  • Regulatory Affairs Manager

    2 settimane fa

    Lazio, Italia Jr Italy A tempo pieno

    Social network you want to login/join with:Job DescriptionWe have an exciting opportunity available for a Regulatory Affairs Manager in Italy.The position is based in Milan, where you will be working in an impactful team, alongside stakeholders that are always trying to reach the next level.You will be part of the Legal, Government and Regulatory Affairs...

  • Manager, Regulatory Affairs

    3 settimane fa

    Lazio, Italia Thermo Fisher Scientific A tempo pieno

    Our site in Ferentino is part of Pharma Services of Thermo Fisher Scientific.We are looking for a talent in Regulatory Affairs Lead for our complex and highly regulated environment within the DPD sterile business unit.**RESPONSIBILITIES**:Regulatory CMC Services:- Assist in quotations preparation and enable proposal at different stages:- Evaluate regulatory...

  • Manager, Regulatory Affairs

    3 settimane fa

    Lazio, Italia Thermo Fisher Scientific A tempo pieno

    **JOB SUMMARY**:Our site in Ferentino is part of Pharma Services of Thermo Fisher Scientific.We are looking for a talent in Regulatory Affairs Lead for our complex and highly regulated environment within the DPD sterile business unit.**RESPONSIBILITIES**:Regulatory CMC Services:- Assist in quotations preparation and enable proposal at different stages:-...

  • Regulatory Affairs Manager, Se

    3 settimane fa

    Lazio, Italia Colgate A tempo pieno

    Job Title: Regulatory Affairs Manager, SE Travel Required?: Travel - 25% of time Date: Feb 20, 2025 Hybrid No Relocation Assistance Offered Job Number164255 - Roma, Lazio, Italy Who We Are Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet...

  • Regulatory Affairs Manager, Se

    2 settimane fa

    Lazio, Italia Colgate A tempo pieno

    Job Title: Regulatory Affairs Manager, SETravel Required?: Travel - 25% of timeDate: Feb 20, 2025HybridNo Relocation Assistance OfferedJob Number#164255 - Roma, Lazio, ItalyWho We AreColgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet...

  • Regulatory Affairs Manager, SE

    2 settimane fa

    Lazio, Italia Colgate A tempo pieno

    Job Title: Regulatory Affairs Manager, SE Travel Required?: Travel - 25% of time Date: Feb 20, 2025 Hybrid No Relocation Assistance OfferedJob Number#164255 - Roma, Lazio, Italy Who We AreColgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet...

  • Regulatory Affairs Officer

    3 settimane fa

    Lazio, Italia Productlife Group A tempo pieno

    Intexo, parte del Gruppo PLG, è alla ricerca di un/unaRegulatory Affairs Officercon almeno due anni di esperienza nel ruolo, da inserire nella propria sede di Roma.Chi siamoIntexo Società Benefit, una realtà di consulenza del gruppo ProductLife, opera nel settore healthcare con l'obiettivo di garantire un accesso rapido, trasparente e sostenibile alle...

  • Regulatory Affairs Officer

    3 settimane fa

    Lazio, Italia Productlife Group A tempo pieno

    Intexo, parte del Gruppo PLG, è alla ricerca di un/unaRegulatory Affairs Officercon almeno due anni di esperienza nel ruolo, da inserire nella propria sede di Roma.Chi siamo Intexo Società Benefit, una realtà di consulenza del gruppo ProductLife, opera nel settore healthcare con l'obiettivo di garantire un accesso rapido, trasparente e sostenibile alle...

  • Regulatory Affairs Manager

    3 settimane fa

    Lazio, Italia JR Italy A tempo pieno

    Social network you want to login/join with: Job DescriptionWe have an exciting opportunity available for a Regulatory Affairs Manager in Italy. The position is based in Milan, where you will be working in an impactful team, alongside stakeholders that are always trying to reach the next level. You will be part of the Legal, Government and Regulatory Affairs...