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Job Title:  Regulatory Affairs Associate_Fixed term contract

Req ID:  31220
Job Category:  Regulatory Affairs

Pomezia, RM, IT, 00071

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

For Cantel Medical Italy, now part of STERIS Group, we are looking for a Regulatory Affairs Associate to join our Regulatory Affairs Department based in Pomezia (RM) for a fixed term contract.

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 Cantel 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.  

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 Cantel 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 on-site guidance as needed for regulatory compliance inspections/audits of Cantel Italy facility.

Duties - cont'd

  • 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 prompt and accurate access to company regulatory information.
  • 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.

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Education Degree

Bachelor's Degree in Science

Required Experience

  • Bachelor’s Degree in a scientific, engineering or technical discipline with 1 year experience in regulatory affairs, preferably in medical devices, or equivalent.
  • Excellent PC skills, including Microsoft Office applications
  • Bilingual skills are mandatory (Italian and English)

Specific Work Preferences

  • Master degree in regulatory affairs, scientific, engineering or technical discipline and professional certification is preferred Developed knowledge of international regulations in the areas of the medical devices/technology, ISO 13485 and EU MDD/MDR.
  • Experience in sterilization and device reprocessing preferred.
  • Proof of strong written and verbal communication skills, especially when dealing with governmental agencies
  • Ability to explain and resolve differences in regulations.

 

#LI-VP1

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  31220
Job Category:  Regulatory Affairs

Pomezia, RM, IT, 00071


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