Regulatory Affairs Specialist

2 settimane fa

Modena, Emilia-Romagna, Italia Capgemini A tempo pieno

Job Description:

Capgemini Engineering is seeking a highly skilled Regulatory Affairs Specialist to join our team in Rome. The successful candidate will be involved in projects related to the biomedical sector and will be responsible for the following activities:

  • Supporting the RAQ&SM and process owners in drafting quality management system procedures in accordance with UNI EN ISO 13485 standards;
  • Supporting in the management, updating, and distribution of quality management system documentation;
  • Collaborating in activities to ensure the dissemination and understanding of quality management system and ISO 13485 standards among all company functions;
  • Collaborating in the management of complaints, non-conformities, corrective and preventive actions;
  • Supporting in the management of critical supplier qualification and verification of maintenance of established requirements;
  • Supporting in the execution of internal audits according to the annual plan and recording of any identified non-conformities;
  • Supporting in the management and preparation of documentation necessary to respond to regulatory requirements;
  • Communicating with distributors and foreign branches for product registration with competent authorities;
  • Supporting in the drafting, updating, and distribution of company documentation related to D. Lgs 81/2008;
  • Supporting in the drafting of documents required by the Vigilance Body;

The ideal candidate will have a specialization in Chemistry and Pharmaceutical Technologies, Pharmacy, Chemistry, Biotechnology, Biomedical Engineering, and 1-2 years of professional experience.

Required skills:

  • Knowledge of CE marking process;
  • Good knowledge of sector-specific regulations (IVDD / IVDR);
  • Knowledge of Regulation (EU) 2017/745 on medical devices;
  • Previous experience in regulatory medical device, pharma, and/or drug-device combination products;
  • Willingness to relocate;

Desirable skills:

  • Problem-solving and priority management skills;
  • Excellent interpersonal skills within a cross-functional international team;
  • Autonomy, proactivity, and critical observation and analysis spirit;
  • Precision and attention to detail;

What we offer:

In Capgemini Engineering, our company's success is driven by our experts. In an international and innovative context, we want to provide them with the best support to accompany our clients in technological challenges, offering stimulating and continuously updated career paths. We are committed to promoting the development of our professionals, involving them in company life to motivate them to improve their performance. Every day, we strive to create an increasingly inclusive environment, allowing our Capgemini Engineering employees to achieve the right balance between private and professional life.

Join our team and discover Values4People, our employee value proposition.

Inclusion & Diversity:

We are committed to improving our collective performance thanks to our inclusive work environment where diverse talents find adequate recognition. Diversity is an essential aspect of our company culture. This is evident in the composition of our employees, who represent 120 nationalities and speak over 100 languages.

Experience level: With experience - Non-management

Contract type: Full-time permanent contract

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