Quality & Regulatory Affairs Specialist EMEA M/F

hace 3 semanas

Cornellà de Llobregat, Barcelona, España ZimVie Inc. A tiempo completo

Select how often (in days) to receive an alert:

Quality & Regulatory Affairs Specialist EMEA M/F

Job Function: Quality Management

Location:

Cornella de Llobregat, B, ES

We are ZimVie , a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions*. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future, and we hope you'll consider being a part of it

Job Mission:

Assist and perform audits, support the quality management system and product registrations.

Also, assist the EMEA QARA team in accordance with the current European regulatory legislation and give support to EU subsidiaries upon Regulatory/Quality requests.

Main Functions:

  • Prepare, review, approve, distribution and training on QMS documentation.
  • Participation on external audits by NBs and Inspections by CAs and performance of internal audits to subsidiaries and suppliers audits.
  • Reporting and management of BCN non conformities and CAPAs.
  • Reporting and management of BCN metrics (KPIs).
  • Management of the BCN suppliers evaluation.
  • Management of destruction of Marketing Material for BCN.
  • Management of pest control activities.
  • Participating in global meetings Management Review (BCN Management Rep.)
  • CAPA Trigger, CAPA Board and Document Change Request (DCR).
  • Respond to all market requests (customers, subs, distributors and others)
  • Prepare the documentation required for custom clearance BCN. Update intranet BCN-VLC.
  • Assessment of new / changes of regulatory requirements for EMEA area.
  • Give support to Medicovigilance (FSCA (Recalls) and FSN for EU area).
  • Registration of products in the EU.

Profile:

  • University degree in a Science related subject.
  • 3-5 years' experience in a similar position. Audit experience preferred.
  • MS Office.
  • Communications and organizational skills.
  • Initiative and flexibility.
  • Mandatory knowledge of ISO 13485: 2016 and fluent English/Spanish (other European languages is a plus).

ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, etc. are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age or sexual identity.

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