Senior RA Specialist 100% (m/f/d)

The Senior RA Specialist works at This AG, the Swiss developer and manufacturer of the Sophi phacoemulsification system, which belongs to the Rayner Group.

Main tasks:

• Management of worldwide registration applications, registrations and product approvals while ensuring correct and up-to-date documentation.
• Support of registration strategies for new products, product changes and lifecycle activities as well as advice during the entire product development.
• Monitor global regulatory requirements, advise internal stakeholders and coordinate timelines and activities for submissions.
• Support exchange with regulatory authorities, audits, inspections, vigilance measures and post-market activities, including change control and CAPA.
• Maintain regulatory databases and calendars, conduct training and work with the regulatory affairs and quality teams to harmonize best practices.

Your profile:

• Over 5 years of experience in the field of Regulatory Affairs for medical devices, including complex projects and international registrations.
• Sound knowledge of the requirements according to FDA 21 CFR Part 820, EU-MDR 2017/745, cGMP and ISO 13485.
• Experience in preparing registration applications and technical documentation as well as dealing with regulatory authorities in global markets.
• Experience in supporting quality management systems and compliance activities in a regulated environment.
• Excellent communication and stakeholder management skills, the ability to identify compliance risks, as well as fluent German and English skills in speaking and writing.