Head of RAQA Sophi

We are seeking a Head of RAQA to join This AG - A Rayner Group Company, at our Heerbrugg site in St. Gallen, Switzerland.

This is an excellent opportunity to manage our RAQA team dedicated to Sophi, the first wireless Phaco system to offer high flexibility and mobility, providing ease of handling in the operating theatre and increased usability.

What You'll Be Doing

• To act as Deputy Management Representative in the Sophi and Lumed business to support the effective management of regulatory affairs and quality assurance within Rayner.

• To immediately highlight any possible risks or failures to meet quality requirements to the Company's attention; to report as required to stakeholders on the performance and results of the RA and QA department, and to help identify options to solve the issue(s).

• To manage, motivate and develop the RA/QA team to achieve high performance.

• To ensure maintenance of systematic records and comprehensive documentation of all RA and QA activities.

• To help drive and support a quality assurance culture and reduce the reliance on quality control.

• To ensure that the Company is properly and adequately aware of and in compliance with relevant and applicable regulatory matters in each of the jurisdictions in which it operates or into which it supplies or intends to supply existing, new or updated product

• To support expansion into new countries and growing our market share, proactively liaising with the Commercial and Marketing teams

• To co-ordinate team resources to ensure achievable project and submission timelines are set and to provide regular updates to senior management on progress.

What Do You Need

• Experience in management of complex Medical Device regulatory projects and QA and QMS activites.

• Greater than 5 years regulatory affairs and international registration submissions experience, including the hosting of audits and inspections.

• Solid working knowledge of cGMP, FDA 21 CFR Part 820 Quality Systems Regulation and related regulations, European Medical Device Directives and ISO 13845 Medical Device Quality Management Systems.

• Experience with, and knowledge of, other ROW regulatory agencies.

• Experience as a budget holder (desirable).

What We Can Offer You

• Private healthcare

• Wellbeing allowance

• A voluntary and additional family allowance