Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

CH - Specialist 2, Regulatory Affairs

Posted Jan 30, 2023
Job ID: JJJP00014383
9 months
(Apr 3, 2023 - Dec 31, 2023)
40 hrs/week
Payrate range
Support compliance execution work for the Powertools business by creation/update of Technical Documentation of existing devices

In this role, typical activities may include:
- Update/maintain the EU MDR Technical Documentation of existing devices to the highest professional standards
- Conduct EU and US Regulatory Assessments of product/process changes
- Lead Global Regulatory Strategies for product/process changes and liaise with WW countries
- Update/maintain internal and external Regulatory databases
- Ensure proper document retention / archiving of all Regulatory documents
- Review and approve Instructions for use, labels and promotional materials after evaluating conformance to regulations

- Master?s degree, relevant regulatory qualifications such as RAC
- Excellent knowledge of US and EU regulatory medical device guidelines
- Previous experience in the Medical Device industry in Regulatory Affairs
- Previous experience with Medical Electrical Equipments and good knowledge of IEC 60601-1 standard
- Knowledge of international medical device requirements (China, Japan, Australia, Brazil, etc.) is a plus
- Excellent written, verbal communication and presentation skills

- English fluent is mandatory (all documentation in English)
The position is based in Oberdorf, Switzerland. The company is working in an hybrid mode combining both remote and office work (typically 3 days in the office / 2 remote).

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