Job Description

This role is to cover a vacancy at Mimetis Biomaterials (https://www.linkedin.com/company/mimetis/), a small medical device company located in Barcelona which is part of Nobel Biocare.

The Quality Assurance and Regulatory Affairs Technician is accountable for timely execution of quality activities and regulatory strategies to support launch activities and maintain compliance status for Mimetis Biomaterials products.

Job Requirements

• Support for the set-up, maintenance and documentation of QMS (writing and updating SOP and WI)
• Ensure the effective implementation of internal procedures and processes.
• Ensure the management of appropriate QA processes (CAPA, Non-conformities, FSCA, Complaints, Document and Change control, etc.)
• Define and implement appropriate Quality actions and trainings
• Support internal and external audits in the audit preparation and audit back office.
• Support Medical Device registration/notification – class III products and technical documentation submission
• Support execution of regulatory strategies for access to main markets EU, US and update product strategy based on regulatory changes.
  
  

Operating Company

Nobel Biocare

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.