Overview
Quality Control Specialist Jobs in Chicago, IL at CellTrans Inc.
CONMED is a global medical technology company that specializes in the development and manufacturing of surgical devices and equipment. With a mission to empower healthcare professionals to deliver exceptional patient care, CONMED is dedicated to innovation, quality, and excellence in all aspects of our operations.
In this role you are working as part of the EMEA team and ensure that all products that are
imported will be compliant according to the EU-MDR regulations. You are controlling market
access to the EU countries through our ERP system. Furthermore, in this role, you will be
working on product verifications that are required for the Authorized representative function
for the EU, Swiss and the UK.
You will be closely working together with the colleagues in the European markets and the US
business units for product approvals and registrations. Furthermore, you will be working with
our distributors in Eastern Europe, Middle east and Africa to drive product registrations.
For this role you will be reporting to the Regulatory Manager in France.
Activities for the French market:
Training and coaching people on the procedures and processes
Review and approve marketing material for the French market
Ensure that local regulations with respect to regulatory compliance,
privacy and ESG are followed
Ensuring that French registrations are done in a timely manner
Importer and Authorized Representative activities:
Regulatory verifications as per Article 13 & 14 of EU-MDR
Technical File review as per required for authorized representative
verification
Regulatory reporting to European authorities for vigilance and field
actions
Follow up and record regulatory registrations for EU countries
Managing Eudamed regisrations as importer and authorized
representative
Monitoring quality objectives and metrics for your area such as in time
vigilance reporting
Manage the regulatory watch process for the EMEA region
Impact assessments in case of product/label changes
Registrations Eastern Europe, Middle East and Africa:
Assist Distributors with submissions for our products
Provide and facilitate notarized and apostilled documents
Inform distributors of impactful product changes
Communicate and register registrations in the global regulatory database
Required Experience and Skills:
Relevant Bachelor’s degree
0-2 years’ experience in a quality assurance or regulatory affairs role
Language skills: good written and verbal English and French communications skills required.
Prefered Skills:
Relevant Master’s degree
3 years’ experience in a quality assurance or regulatory affairs role
Good knowledge of local and European Medical Device regulations
Certification as auditor for ISO9001 or 13485 is preferred
IT literacy, experience with using Microsoft Office applications,
Strong communication skills
Passion for quality and to do things right
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Title: Quality Control Specialist
Company: CellTrans Inc.
Location: Chicago, IL
