Head of Quality and Regulatory Affairs Robotics 80 - 100 % (f/m/d)

Company Overview

At Hamilton Bonaduz AG, we are committed to our vision of driving innovation to enhance people's lives. Since our establishment in 1950, we have been at the forefront of providing solutions within the health sector, specializing in ventilators, automated pipetting, sample management, and process sensor development.

About the Business Unit Robotics

The Business Unit Robotics designs, produces, and distributes pipetting robots aimed at automating liquid handling processes for a diverse clientele, including sectors such as pharmaceuticals, food industry, and cell and DNA research.

Your Impact

As a key leader in our organization, you will guide teams in Quality Assurance, Regulatory Affairs, and Validation & Verification, acting as a strategic partner to the Robotics Management Team, R&D, and Commercial organization. Your role will be pivotal in developing regulatory intelligence, quality compliance, and fostering quality awareness throughout the business unit.

• Ensure quality assurance and compliance within the Business Unit, overseeing product and process conformity with all relevant standards, while managing internal audits.
• Strengthen quality awareness and advise colleagues on regulatory requirements.
• Develop regulatory affairs strategies for global registrations, with a primary focus on EU and Asia, ensuring cooperation with the Quality Management team in Reno, USA for FDA registrations.
• Collaborate with cross-functional partners to standardize and implement systems and processes for monitoring regulatory changes impacting business products and goals.
• Support corporate QA management initiatives, including the development of the Quality Management System (QMS) and monitoring the CAPA process.
• Work closely with R&D, Product Management, Operations, and commercial teams to keep them informed about changes in regulatory and quality requirements.
• Manage the budget and resource planning for your department.
• Contribute to the continual development of the Business Unit's strategy, structure, goals, and processes.

Your Qualifications

• A degree in natural sciences or engineering, coupled with significant professional experience in Regulatory Affairs and Quality Management within the GxP, IVD, or medical device industry.
• 3-5 years of direct experience in RA/QA roles, with at least 10 years of experience related to design and development, verification, and validation for IVDR, MDR, or GMP compliant products.
• Familiarity with relevant quality management tools, systems, and methodologies.
• Deep understanding of how culture, processes, and initiatives affect quality.
• Proficiency in major regulations and QM-Standards: ISO 13485, ISO 9001, FDA 21 CFR Part 11, GMP, GAMP, IVDR, and 2006/42/EG.
• Experience in design control and risk management, especially in design and development activities including commercialization.
• Proven leadership in change and project management to engage your team in achieving shared goals.
• A pragmatic approach to streamlining key processes.
• Fluency in English and German, with excellent communication and negotiation skills.

Join Us

If you resonate with our values and thrive in a collaborative and straightforward environment, Hamilton offers a motivating workplace with various leisure activities and modern working conditions. We foster open communication at all levels, creating a pleasant working atmosphere where your skills are respected, and innovative ideas are encouraged.

Discover more about potential career paths at Hamilton at jobs.hamilton.ch.