European RA Product Compliance Specialist PPE/Cleanroom
Bucharest, ROU
2 zile în urmă

Ensure Business is timely and correctly informed on the latest requirements and upcoming changes of regulations, addressing occupational health, safety and controlled environment (PPE Regulation) as well as future compliance trends in EMEA & APAC.

Identify and secure legal tracking tools (databases, newspapers, etc.) for the applicable legislation.

Work within Regulatory Affairs team on other legislative areas (low voltage devices, RoHS, Medical devices)

Job duties and responsibilities :

  • Identify and follow up on upcoming and updated European legislation addressing product Safety and market needs affecting products by utilizing tracking tools and network·Analyse regulatory requirements ·Monitor EU Oj publications to identify any newly listed standards·Coordinate, review and consolidate the analysis of local regulatory requirements done by local regulatory responsible
  • Draft and define, in cooperation with stakeholders, instructions with appropriate conformity actions for Business. ·Give input and work together with Port Folio Management and OEM to secure compliant products are placed on the market.
  • Advice Business, local Regulatory Affairs responsible, local sales / marketing in compliance matters ( e.g requirements for new products, interpretation of regulations and standards, etc.
  • Act / report proactively when recognizing significant business risk for VWR.·Assist local Regulatory Affairs Responsible in contacts with governmental bodies, towards Market Surveillance in case of non-compliance or any enquiry.

  • Maintain close relationship with other business groups ( e.g. Sourcing, Port Folio Management, Sales, QA etc)·Monitor competitors and OEM practices to understand the market and assess the risks·Participate in / lead product compliance related projects
  • Knowledge, Skills, Abilities and Competencies :

  • Master degree in sciences,
  • 5 years experience in PPE or occupational health, controlled environment, Safety, Hygiene
  • Committed to ensure the health and safety on the workplace
  • Interest in regulatory compliance matters
  • Knowledge of, or particular interest for the following legislation : New Legislative Framework (NLF), CE MarkingEU Personal Protective Equipment regulationsEU Biocidal Product RegulationsEU Cosmetic RegulationsEU ISO Cleanroom Standards
  • Ability to analyse, interpret regulatory requirements and define necessary actions
  • Well versed in risk assessment techniques and hazard identification, and conveying your understanding to a variety of audiences
  • Advanced communication and networking skills
  • Team player in multicultural environment
  • Fluent in English
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