Trumpf Medical develops and manufactures medical equipment for operating rooms, intensive care units, and related clinical areas that provide high quality support for hospital staff and the efficient and safe care of patients. In hospitals and especially in the operating room, rapid, smooth workflows are of life-saving importance. Digital systems and automated devices are becoming more prevalent in order to help streamline workflows, improve user comfort and promote patient safety. In consideration of these developments, Trumpf Medical is setting new standards with its OR solutions.
Trumpf Medical is a part of Hillrom. Hillrom, with three global business units, has a comprehensive product line that delivers solutions in hospitals, doctors’ offices and long-term care facilities. With sales of approximately $2.7 billion, the Company employs more than 10,000 people around the world. It is pursuing an aggressive organic and acquisition strategy for growth.
We are looking for a Regulatory Affairs Specialist (m/f/d) for our location in Puchheim (Munich) with specific expertise in Radio registrations globally
Be Regulatory Affairs Subject Matter Expert on Radiotelecommunication regulations globally for medical devices including WiFi components.
Submit and monitor radio registrations globally and organize testing with external test houses.
Provide regulatory input to new product developments and product lifecycle planning for our Trumpf Medical products (mainly class I devices, operating tables and operating lights and their accessories)
Determine submission and approval requirements and keep regulatory submission timelines
Minimum Bachelors Degree in Science or Engineering
Minimum 3 years of Regulatory Affairs experience in the Medical Device industry, preferably with medical electrical devices
Good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards and Global Regulatory submission requirements
Knowledge in CE marking according to MDR
Good knowledge in Radio registration requirements and implementation of labeling requirements from Radio regulations.
Ability for strong attention to detail in a complex work environment with multiple and competing registration priorities
Good planning and organizational skills
Basic analytical and problem-solving skills
Basic Project Management Experience, ideally with supporting new product developments and launches
Strong internal customer service orientation with “do whatever it takes” attitude
Strong team player within Trumpf Mediacal RA team, other functions and international Hillrom RA colleagues
Experience working with SAP is preferred
Excellent English communication skills are a must, good German knowledge required
To apply please use the online job application tool on our website www.trumpfmedical.com including information on your notice period and salary expectations. Please send all documents in English. If you still have questions, please contact Julian Förtsch from the Human Resource Department.
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