Lavori attuali relativi a Regulatory Affairs Specialist - Roma, Lazio - Elettronica S.p.A.
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Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno{"title": "Regulatory Affairs Manager", "company": "Meditrial Europe Ltd.", "location": "Rome, Italy", "job_type": "Full-time", "industry": "Lifescience", "function": "Regulatory Affairs", "responsibilities": ["Management of CTD (Electronic Common Technical Document)", "Collaboration during implementations of regulatory strategies for New MA through...
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Medical Affairs Specialist
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Regulatory Affairs Specialist
3 mesi fa
- Management of chemical products and articles purchased and sold by the company, in compliance with European regulations.
- Ensure the verification and control of the documentation relating to raw materials and CLP labeling as well as the safety data sheets of suppliers (EU/nonEU);
- Provide specific analysis of the chemical risk of articles, substances and mixtures through the technical documentation and tools made available by the company in order to guarantee the protection of employees and customers (end users);
- EU suppliers and customers (conformity declarations, general compositions, various declarations) also through direct contact with customers/suppliers;
- ensure the necessary support for product safety design through the development of technical solutions and specific analyzes by supervising the various review phases, possibly also with suppliers and customers.
Technical Requirements
- Indepth knowledge of the main EU regulations relating to chemistry (REACH regulation, CLP regulation, "Dual Use" regulations, "Conflict Minerals", "RoHS", "POP", etc.); knowledge of ADR / Seveso regulations is appreciated.
- Knowledge of Italian legislation on Health and Safety in the Workplace, experience in certifications is welcome, including ISO 45001, ISO 1400
- Knowledge of the ECHA IUCLID tool: preparation of PCN notification dossiers, REACH inquiry and registration dossiers, SCIP notification, CLP notification.
- Master's degree in chemical engineering or in the chemical field
- At least 3 years of experience in a similar role of in production contexts, preferably in the aerospace and defense sector
- Good knowledge of spoken and written English.