Regulatory Affairs Specialist

OVERALL RESPONSIBILITIES 

Support compliance execution work for the Powertools business by creation/update of Technical Documentation of existing devicesIn 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

Qualifications:

• 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 skillsLANGUAGE

• 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)

Thank you very much and we look forward to receiving your application.

Inclusion & Diversity

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!