True to the vision of "We drive innovation to improve people's lives," Hamilton has been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management, and the development of process sensors.
The Business Unit Robotics develops, produces, and distributes pipetting robots for the automation of liquid handling processes, catering to a diverse range of customers in the pharmaceutical and food industries, as well as in cell and DNA research.
How You Can Make a Difference
The Head of Quality and Regulatory Affairs is a seasoned leader responsible for guiding a transforming organization and teams in Quality Assurance, Regulatory Affairs, and Validation & Verification. This position acts as a business and sparring partner for the Robotics Management Team, R&D, and the Commercial organization.
The main responsibilities include:
Ensuring quality assurance and compliance within the Business Unit, as well as conformity of products and processes with all relevant standards, and overseeing internal audits.
Strengthening and promoting quality awareness within the Business Unit and advising colleagues on quality-related and regulatory requirements.
Developing and executing regulatory affairs strategies for global registrations, focused on the EU and Asia (including IVDR, Machine Directive, GxP), while closely cooperating with the Quality Management team at Hamilton Company in Reno, USA for global strategies aimed at FDA registrations.
Collaborating with cross-functional partners to define and oversee the standardization and implementation of systems/processes/communications to monitor the regulatory environment for changes affecting business products and goals.
Supporting business segment initiatives identified by Corporate QA management, e.g., the Quality Management System (QMS), monitoring the CAPA process, and other regulatory requirements.
Working closely with R&D departments, Product Management, Operations, and the commercial organization to provide early insights on the effects of regulatory and quality requirement changes.
Managing the budget and resource planning for your department.
Contributing to the continuous development of the Business Unit Robotics: strategy, structure, goals, and processes.
What You Bring Along
A degree in natural sciences or engineering, paired with several years of professional experience in Regulatory Affairs and Quality Management in the GxP, IVD, or medical device industry; advanced business training is a plus.
A minimum of 3-5 years of experience in RA/QA roles and over 10 years overall, encompassing design and development, verification and validation activities, or other aspects necessary to achieve IVDR, MDR, or GMP compliant products.
Familiarity with relevant quality management tools, systems, and methods.
A strong understanding of how culture, processes, and suitable initiatives influence quality.
Profound knowledge of regulations and major QM standards: ISO 13485, ISO 9001, FDA 21 CFR Part 11, GMP, GAMP, IVDR, 2006/42/EG.
Good understanding of design control and risk management requirements, gained from experience in design and development activities, including commercialization.
Leadership, change, and project management experience that enables you to engage and develop your organization towards common goals.
A knack for pragmatic approaches that streamline key processes.
Excellent communication and negotiation skills in both English and German.
Learn more about career opportunities at Hamilton at jobs.hamilton.ch.
Do you share our values and thrive in a collaborative, down-to-earth environment? At Hamilton, we not only offer a motivating work culture but also a range of leisure activities and modern working conditions. Our commitment to open communication fosters a pleasant working atmosphere. Become part of a team that values your skills and encourages innovative ideas. Interested? Then apply online using the form below. Please note that only applications matching the job profile will be considered.
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