Consultant MDR (m/f/d)

REFERENCE NUMBER:

617854/1

MY DUTIES:

- Support the remediation or creation of Endodontics Technical Dossiers (TD), Technical Files (TF) and Design History Files (DHF) according to the applicable international regulations and standards (e.g., EU MDR) and more specifically OEM/PLM Business (Private Label, Value Brand, Customers acting as legal manufacturer)
- Create specific MDR Technical Dossiers for OEM/PLM based on existing legacy Technical Dossiers.
- Integrate Manufacturing Change Controls or Design Change Controls in the TD
- Conduct Gap assessment on old technical files
- Interact with OEM/PLM Marketing Team based in Zhermack/IT and Munich/D to understand remediation timeline needs and customer’s needs in term of Technical Dossier
- Interact with R&D (Ballaigues CH) to define scope of potential necessary retesting. Review Test protocols and Test reports (acceptance criteria, deviations, sample size justification etc.…)
- Work closely with multifunctional team to ensure compliance with design control, safety, functional goals requirements in accordance with internal, and applicable external requirements (Corporate, Consumable Group, FDA, MDD, MDR...)
- Responsible for identifying the applicable standards & regulations specific to the product
- Responsible for the conformity of all product labelling associated to the product (UDI, IFU, Brochure, Web etc...).
- Review and approve deliverables generated during the remediation project for accuracy and compliance (design inputs, V French and/or German and/or Italian would be a plus
- Strong team player with the ability to build productive relationships in a dynamic international environment
- Autonomous and independent decision-taker
- Result-orientation combined with conscientiousness in execution
- Excellent knowledge of Office Suite

MY BENEFITS:

- Interesting tasks in an innovative company

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

MY CONTACT AT HAYS:

My contact person
Laura Feig

Reference number
617854/1

Contact
E-Mail: [email protected]
Phone: +41-(0)61-2250522