Head of Quality and Regulatory (m/w/d) for Medical Software at TOMTEC in Munich

Job Description

Job Title

Job Description

In this role you have the opportunity to

make a difference by providing strategic direction and leadership regarding all aspects of the Quality and Regulatory areas at TOMTEC in Unterschleißheim. By doing so, you help to ensure state-of-the-art medical /clinical software applications that maximizes the benefit of digital healthcare for both physicians and patients.

Responsibilities

• Identifying and implementing standard methodologies to improve efficiency and maintain compliance and lead the function in continuous process improvement.
• Leading, developing and mentoring a team of Q&R professionals responsible for TOMTEC solutions.
• Reviewing and maintaining an effective Quality Management System.
• Ensuring that regulatory strategies adequately support product development activities and result in the timely approval of new and revised products.
• Representing the business during any audit, internal or external. Driving compliance across all functions of the business and ensuring preparedness for any audits.
• Working closely with quality and regulatory leaders of our ultrasound business in the US and with the leadership team at TOMTEC.
• Maintaining productive working relationships with external regulatory bodies.
• Implementing appropriate activities to ensure regulatory compliance and adherence effectiveness of the quality system such as: complaint handling, corrective and preventive action, and the internal audit program.
• Monitoring external changes to the regulatory environment to ensure the continued compliance of the quality system.

You are a part of

the Management Team at TOMTEC in Unterschleißheim and collaborate closely with the ultrasound quality and regulatory leaders in the US. In this role you will report into the Sr. Director Ultrasound Quality & Regulatory.

To succeed in this role, you should have the following skills and experiences

• Minimum of a Bachelor's degree in Science, Engineering or similar technical discipline.
• Minimum of 10 years working experience in the area of medical device quality, experience in medical software quality preferred.
• Minimum of 5 years leading experience.
• Experience with FDA and other worldwide standards and regulations as well as in leading and supporting both internal and external audits.
• Experience in maintaining an effective Quality Management System.
• Strong stakeholder management and communication skills.
• Solution-driven, customer-focused and team-oriented.
• Fluent English skills, German skills are a plus.

In return, we offer

• Working in a motivated team
• Versatile, challenging tasks in a growing company in an international environment
• An innovative environment with the chance to evolve
• An excellent working atmosphere with flat hierarchies and short decision makings
• An attractive and dynamic salary package, excellent employee benefits and supplementary pension
• Flexible trust-based working hours, massages, sports courses, regular team events and much more

Please apply online via our website with your full application

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