RA and Compliance - Lead Specialist in Duisburg at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

Job Description

Regulatory Affairs

  • Ensure that all local regulatory requirements are met before release of any product in the local market
  • Mointain records for all approved products and ensure a timely notification to business partners in case of product license expiry
  • Provide adequate and up-to-date documentation (ISO & CE Certificates, Declarations of Conformity and other customer-specific documents upon request ( tenders or special projects)
  • Ensure compliance with any new European/ local applicable regulation (packaging, battery, REACH, WEEE directives IEC, etc,)
  • Liaise with Distributors/ Local Competent Authorities /local Trade Associotions to ensure that any change in loco/ requirements is identified timely and reported to the relevant stakeholders

Post Market Surveillance

  • Ensure that the Stryker EU post marketing vigilance SOP’s are properly delivered and implemented
  • In line with these procedures, liaise with the relevant authorities and with Customers when Complaints / product liability matters
  • Ensure that product legacy data (products traceability) are consistently and safely maintained.
  • Monitor the closure of RA actions initiated for Poland and/or other regions and report progress as appropriate to local and European stakeholders.

Work From Home: No

Travel Percentage: None


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