Head of RAQA Sophi

The Head of RAQA is employed at This AG, the Swiss developer and manufacturer of the Sophi phacoemulsification system, which belongs to the Rayner-Gruppe.

In this role, you will lead the activities in the areas of Regulatory Affairs and Quality Assurance for the business units Sophi and LUMed and report to the Director of Regulatory Affairs of Rayner, while working closely with the regulatory, quality, and business teams of the entire group.

Please note that this position is based 100% at our headquarters in Heerbrugg, St. Gallen.

Your profile:
Experience in leading complex regulatory projects for medical devices as well as in RA/QA activities
More than 5 years of experience in the field of Regulatory Affairs and with international registration applications, including conducting audits and inspections
Sound knowledge of cGMP, the FDA 21 CFR Part 820 regulations for quality management systems and related regulations, Regulation (EU) 2017/745 as well as ISO 13485 for quality management systems for medical devices
Experience with and knowledge of other regulatory authorities in other countries
Experience in quality management in a regulated environment
Leadership/management of multidisciplinary teams
Fluent German skills, professional business English skills
Experience as a budget holder (desirable)

What we can offer you:
Comprehensive global benefits package
Wellness allowance
Annual program with entertaining events
You will become part of an organization that you can be proud of and that changes the lives of millions of people!