Head of Regulatory Affairs
About the Company
Innovative medical technology company
Industry
Hospital & Health Care
Type
Privately Held
About the Role
The Company is seeking a Head of Regulatory Affairs to lead and advance the regulatory function at both national and international levels. The successful candidate will be responsible for ensuring the compliance of all products with relevant regulatory requirements, including but not limited to, EU MDR, FDA, and ISO standards. This role involves providing expert guidance to internal development teams on regulatory matters, planning and executing approval strategies for new and existing products, and managing the preparation and support of approval processes in various global markets. The Head of Regulatory Affairs will also be tasked with overseeing audits, inspections, and interactions with regulatory bodies, as well as fostering collaboration with cross-functional teams to ensure efficient product launches and ongoing market surveillance. Applicants for the Head of Regulatory Affairs position at the company should hold a degree in a scientific or engineering discipline, with a preference for a background in medical technology, biomedicine, or a related field. A minimum of 5 years' experience in regulatory affairs within the medical device industry, particularly in a leadership role, is required. The ideal candidate will have a deep understanding of the relevant regulatory standards and experience in the approval process for medical devices. Strong leadership skills, excellent communication in both German and English, and the ability to manage a dynamic team of regulatory affairs professionals are essential. The role offers the opportunity to work in a dynamic and innovative environment, with a focus on advancing healthcare through the development of cutting-edge solutions.
Travel Percent
Less than 10%
Functions
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