Senior Regulatory Affairs Specialist – Global Submissions

Rayner; Sankt Gallen; On-site; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Global recognition

Growth opportunities

Pride in making a difference

Job summary

Rayner seeks a Senior RA Specialist to join its Swiss HQ in Heerbrugg, St. Gallen, on-site.

Lead regulatory submissions and registrations for global markets, and provide regulatory expertise across Sophi and LUMed products within the Rayner Group. The role requires 5+ years in medical device regulatory affairs, fluency in German and English, and experience with audits, inspections, and multi-market submissions for ophthalmic devices.

Qualifications

• Experience in management of complex Medical Device regulatory projects and Regulatory Affairs activities.
• Greater than 5 years regulatory affairs and international registration submissions experience, including interactions with regulatory authorities.
• Solid working knowledge of cGMP, FDA 21 CFR Part 820 and EU MDR / ISO 13485 regulatory frameworks.
• Experience with ophthalmic medical devices and audits/inspections.

Responsibilities

• Lead the preparation, compilation and maintenance of regulatory submissions for global markets.
• Support regulatory strategies for new products and lifecycle activities.
• Maintain documentation of regulatory activities and submissions.
• Provide regulatory input during product development and cross-functional reviews.
• Coordinate activities with stakeholders to ensure timelines and compliance.
• Respond to regulatory authority questions and support agency interactions.
• Maintain submission calendars and databases of registrations worldwide.

Skills

Regulatory affairs

Medical device submissions

cGMP knowledge

EU MDR ISO13485

International registrations

Quality management

Stakeholder management

Fluent German & English

Ophthalmic devices

Audits & inspections

eQMS / document control

Multi-market experience

Job description

Rayner seeks a Senior RA Specialist to join its Swiss HQ in Heerbrugg, St. Gallen, on-site.

Lead regulatory submissions and registrations for global markets, and provide regulatory expertise across Sophi and LUMed products within the Rayner Group. The role requires 5+ years in medical device regulatory affairs, fluency in German and English, and experience with audits, inspections, and multi-market submissions for ophthalmic devices.