Regulatory Affairs Intern

05/07/2024
SEDE LAVORO
Pomezia
CONTRATTO
Stage, Tirocinio
AREA D'INSERIMENTO
Affari Regolatori
SETTORE
Pharma

Job Title: Regulatory Affairs Intern
Job Category:  Regulatory Affairs

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

We are looking for a Regulatory Affairs Intern to join our team base in Pomezia (Roma). 

The mission of the STERIS Regulatory Affairs function is to implement efficient and effective processes to initially obtain and then maintain clearance to market STERIS products in support of STERIS’s global business plans. This includes determining submission to NB for the CE marking and in some cases of registration and/or submission requirements in the International markets, working with STERIS International Registration staff to identify requirements in other targeted markets, and working with product acquisition or development teams to ensure these requirements are met.

The Regulatory Affairs Intern will develop a working knowledge of the following market and the regulations and standards associated:

Europe/Middle East/Africa (EMEA)

  • ​​​European Union: Medical Device Directive 93/42/EC as amended by 2007/47/EC 
  • EU MDR Regulation 2017/745

Key International Standards:

  • ISO 13485: Medical devices – Quality management systems
  • ISO 9001: Quality management systems
  • ISO 14971 Application of Risk Management to Medical Devices

The Regulatory Affairs Intern will have responsibility to support the duties of the functional areas described below, as assigned, under the guidance and direction of his/her manager and other senior Regulatory Affairs staff.

General Duties

  1. Responsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to his/her job functions.
  2. Maintain conduct in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
  3. Protect company confidential information by properly storing, retrieving, and disseminating such information only to those authorized.
  4. Conduct daily activities of assigned job responsibilities and projects as assigned.
  5. Support a safe, clean and secure working environment through adherence to applicable procedures, rules and regulations.
  6. Assist in the updating and maintenance of essential requirements and GSPR checklists and technical files for products sold into the EU market.  Assist to complete change control documentation for regulatory related product changes.
  7. Support in the execution of regulatory affairs and compliance activities for company product lines in both the Italian and international markets in which the Company conducts business.

Registration and technical Duties

  • Support in the preparation, monitoring and maintenance of documents for any submissions to NB and shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
  • Assist in the preparation, compilation, and submission of regulatory documents for the registration of current and new products in some markets.
  • Assist in Monitoring and maintenance of regulatory documents to keep the CE marking.
  • Support local commercial and tender offices with RA documentation/information.
  • Interact with Regulatory Affairs personnel at regulatory agencies, including NB, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate to avoid any potential delays in approval.

Education Degree

High School Diploma
Bachelor's Degree in Engineering General or Biology

Specific Work Requirements

  • Excellent PC skills, including Microsoft Office applications.
  • Italian mother tongue and English fluent are mandatory.

Competencies

  • Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
  • Self-starter that is highly organized.
  • Strong oral and written communication skills.