Regulatory Affairs Associate

1 settimana fa

Pomezia, Lazio, Italia Adecco Italia A tempo pieno
La specializzazione Lifescience del Gruppo Adecco ricerca per un'azienda leader del Settore Medicale:
Regulatory Affairs Associate

Reports To

Regulatory Affairs Manager

Position Summary


The Regulatory Affairs Associate supports and improves the local regulatory compliance position by completing regulatory affairs tasks to help achieve RA departmental and overall business objectives.

Responsible and accountable for regulatory affairs and compliance activities for all company product lines in both domestic Italian and international markets with focus with on the Company Italy business.

Assist in the determination of regulatory pathway and requirements for new and revised products and project teams throughout the company.

Plan, develop, prepare and submit regulatory submissions to appropriate agencies both domestic Italian and international markets. Facilitate achievement of business objectives while ensuring compliant operation within the flexibility of the regulations.

Si offre un contratto a tempo determinato di 1 anno alle dirette dipendenze dell'azienda.

Responsabilità:

Duties:

  • Support in the regulatory affairs and compliance activities for company product lines in both domestic Italian and international markets focus on with on the Company Italy business. Support to ensure company products and operations comply with applicable international standard requirements included ISO 13485 and EU MDD/MDR requirements.
  • Assist in development and execution of regulatory strategies. Review and support regulatory implications of product, labeling and/or other documentation or design changes.
  • Participate on project teams to provide regulatory support and input. Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need and importance of regulatory requirements.
  • Support in the international RA submissions activity in accordance with business objectives, with a focus on CH and UK requirements.
  • Support the local Manager in the PRRC activities and the local RA Team in MDR remediation plan and submissions.
  • Collaborate with management in establishing departmental strategies and procedures in support of business objectives.
  • Provide support and onsite guidance as needed for regulatory compliance inspections/audits of Company Italy facility.
  • Prepares, compiles, and submits regulatory documents for the registration of current and new products in international markets.
  • Maintain submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure promp
  • Monitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectations.
  • Monitor approved registrations in respect to expiry and ensure management is aware of action required to renew in a timely manner to ensure no disruption in product distribution.
  • Interact with Regulatory Affairs personnel at regulatory agencies, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate to avoid any potential delays in approval.
Data inizio prevista: 26/06/2023

Categoria Professionale:
Scientifico / Farmaceutico

Città:
Pomezia (Roma)

Conoscenze linguistiche:

  • Inglese
  • Livello Ottimo

Mezzi di trasporto:

  • Auto

Disponibilità oraria:

  • Full Time
Benefit previsti: 2 giorni di Smart Working

ATTENZIONE:

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Adecco Italia S.p.
A. (Aut. Min. Prot. N.1100-SG del

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