Regulatory Affairs Specialist
6 giorni fa
Capgemini Engineering is seeking a 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 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 contents and ISO 13485 standard among all company functions;
- Collaborating in the management of Complaints; Non-Conformities; Corrective and Preventive Actions;
- Supporting in the management of critical supplier qualification process (also in terms of Health and Safety at Work) and verifying the maintenance of established requirements;
- Supporting in the execution of internal audits according to the annual plan and recording any Non-Conformities or possible Corrective Actions;
- Supporting in the management and preparation of documentation necessary to respond to product requirements and for registrations with national and foreign competent authorities;
- Communicating with distributors and foreign branches for product registrations with local 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;
You will work in the Energy, Industry & Life Sciences industry, which has multiple objectives: investing in cleaner energy sources, investing in new technologies to remain competitive, and combining technological progress and medicine, looking at a completely patient-centered model. The common denominator of the three sectors is the challenge of the digital revolution, which represents the pivot of the great change from which to take advantage. EILIS aims to support its clients in these challenges.
About YouThe ideal candidate has a Specialist Degree in Chemistry and Pharmaceutical Technologies, Pharmacy, Chemistry, Biotechnology, Biomedical Engineering, and has gained 1 to 2 years of professional experience.
Essential requirements:
- Knowledge of CE marking process;
- Good knowledge of sector-specific regulations (IVDD / IVDR);
- Knowledge of Regulation (EU) 2017/745 on medical devices;
- Prior experience in regulatory medical device, pharma, and/or drug-device combination products;
- Tendency to mobility.
Our Recruiters recommend that you apply to this offer if you have:
- Problem-solving skills and priority management;
- Excellent interpersonal relationship-building skills within an international cross-functional team;
- Autonomy, proactivity, and critical observation and analysis spirit;
- Precision and attention to detail;
What We Offer:
In Capgemini Engineering, company success is driven by our experts. In an international and innovative context, we want to put them in the best position to support our Clients in technological challenges, proposing stimulating and constantly updated career paths in line with the needs of a constantly evolving market. We commit to developing the potential of our professionals, involving them directly in company life to motivate them to improve their performance. Every day, we strive to create an increasingly inclusive environment, allowing those who work in Capgemini Engineering to achieve the right balance between private and professional life, and we have chosen to build business relationships based on trust, teamwork, and a sense of responsibility.
Join Capgemini Engineering. 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 valorization. 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. Expanding our horizons through dynamics related to experience, culture, ethnicity, company behavior rules, personality, and communication, diversity welcomes the best of all worlds in its theory of unity. In addition, we pay attention and sensitivity to future resources belonging to protected categories, pursuant to Articles 1 and 18 of Law 68/99. Personal data will be processed in accordance with the provisions contained in Regulation (EU) 2016/679.
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