Join Our Vision at Hamilton
At Hamilton, we are dedicated to our mission: "We drive innovation to improve people's lives." Since 1950, we have been transforming the health sector by providing cutting-edge solutions in ventilators, automated pipetting, sample management, and process sensors. Our Business Unit Robotics designs, manufactures, and distributes pipetting robots that automate liquid handling processes for diverse clients, ranging from the pharmaceutical and food industries to cell and DNA research.
Your Impact as Head of Quality and Regulatory Affairs
We are seeking an experienced leader for the role of Head of Quality and Regulatory Affairs. In this pivotal position, you will:
- Lead and guide teams in Quality Assurance, Regulatory Affairs, and Validation & Verification during a transformative phase.
- Act as a business partner and advisor to the Robotics Management Team, R&D, and Commercial organization.
- Develop Regulatory Intelligence, enhance Quality Compliance and Awareness, and provide internal education to key departments.
- Enable market access for innovative, safe, and reliable laboratory automation technologies.
- Ensure compliance within the Business Unit and maintain conformity with relevant standards through internal audits.
- Promote quality awareness and advise colleagues on quality and regulatory requirements.
- Develop and implement regulatory affairs strategies for global registrations, focusing on EU and Asia, while collaborating with the Quality Management team in the USA for FDA registrations.
- Define and oversee the standardization and implementation of systems and processes to monitor regulatory environment changes impacting business goals.
- Support corporate QA initiatives such as monitoring the CAPA process and other regulatory requirements.
- Collaborate with R&D, Product Management, Operations, and commercial teams to provide insights on regulatory and quality requirement changes.
- Manage budget and resource planning for your department.
- Contribute to the continuous development of the Robotics Business Unit in strategy, structure, goals, and processes.
Your Qualifications
The ideal candidate for this position will possess:
- A degree in natural sciences or engineering, with several years of experience in Regulatory Affairs and Quality Management within the GxP, IVD, or medical device industry; advanced business training is a plus.
- A minimum of 3-5 years in RA/QA roles, with over 10 years overall experience in design and development activities, including verification and validation for IVDR, MDR, or GMP compliance.
- Familiarity with relevant quality management tools, systems, and methods.
- A comprehensive understanding of how culture, processes, and initiatives impact quality.
- Profound knowledge of regulations and major quality management standards: ISO 13485, ISO 9001, FDA 21 CFR Part 11; GMP; GAMP; IVDR, 2006/42/EG.
- Experience in design control and risk management requirements relevant to design and development activities.
- Proven leadership, change management, and project management capabilities to engage your team towards common goals.
- A pragmatic approach to streamline key processes.
- Excellent command of English and German as well as exceptional communication and negotiation skills.
At Hamilton, we offer a motivating work environment along with various leisure activities and modern working conditions. Our culture promotes open communication and collaboration, creating a pleasant workplace. Become a part of a team where your skills are valued, and innovative ideas are encouraged.
Apply online using the form below. Only applications matching the job profile will be considered.