Senior RA Specialist (Sophi) in Sankt Gallen

The Senior RA Specialist sits within This AG, the Swiss developer and manufacturer of the Sophi phacoemulsification system and part of the Rayner Group.

The role supports Regulatory Affairs and Quality Assurance activities for the Sophi and LUMed businesses and will report to the Head of RAQA Sophi, while working closely with Regulatory, Quality and business teams across the wider Group.

The role is responsible for leading regulatory submission activities, supporting regulatory compliance, maintaining registrations and providing regulatory expertise throughout the product lifecycle.

Please note this role is based 100% on-site at our HQ in Heerbrugg, St. Gallen.

What You'll Be Doing:

• Lead the preparation, compilation and maintenance of regulatory submissions and registrations for global markets.
• Support the development and execution of regulatory strategies for new products, product changes and lifecycle activities.
• Maintain systematic records and comprehensive documentation of regulatory activities and submissions.
• Support product development activities by providing regulatory guidance and input throughout the design and development process.
• Ensure the Company remains aware of and compliant with applicable regulatory requirements in jurisdictions where products are marketed or intended to be marketed.
• Coordinate regulatory activities with internal stakeholders to ensure achievable project and submission timelines are established and maintained.
• Prepare responses to regulatory authority questions and support interactions with regulatory agencies, distributors and external stakeholders.
• Maintain regulatory submission calendars and databases of registrations and approvals worldwide.
• Participate in change control, CAPA, complaint and post-market activities from a regulatory perspective and ensure regulatory documentation remains current following approved changes.
• Support inspections and audits by Notified Bodies and National Competent Authorities.
• Support vigilance and post-market regulatory activities as required.
• Keep up to date with developments in regulatory requirements and communicate relevant changes to the business.
• Provide regulatory training and guidance to internal stakeholders.
• Work closely with the Rayner Surgical Group Limited network of Regulatory and Quality professionals to harmonise best practices.

What Experience & Skills You Will Need:

• 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 Quality Systems Regulation and related regulations, Regulation (EU) 2017/745 and ISO 13485 Medical Device Quality Management Systems.
• Experience with, and knowledge of, other ROW regulatory agencies.
• Experience supporting Quality Management activities in a regulated environment.
• Experience preparing and maintaining regulatory submissions, registrations and technical documentation.
• Strong communication and stakeholder management skills.
• Ability to independently identify compliance risks and escalated when necessary.
• Fluency in both German and English languages, spoken and written.
• Experience with ophthalmic medical devices.
• Experience supporting audits and inspections.
• Experience with document management systems and eQMS platforms.
• Additional language skills.
• Experience working across multiple international markets.

What We Can Offer You:

• Global appreciation platform to recognise colleagues around the globe
• Fantastic opportunity to work with highly talented teams and individuals and grow with the business
• Being part of an organisation you can be proud to work for changing the lives of millions of people!

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