Head Regulatory Affairs (m/f/d)

Job Description

As Head of Regulatory Affairs you will manage a team of currently 4 internal employees. The group is responsible for global submissions and requirements related to Class I, II and III medical devices in the EU and the United States. Combination products will be developed and released with an pharmaceutical partner as legal manufacturer with contribution for submission from Gerresheimer Olten. You provide leadership to cross-functional teams during new product development. You have the functional responsibility for development projects from the feasibility phase to the timely approval of products in international markets. Therefore you work in a close cooperation with other departments like Development, Product Management, Medical and Quality.

Furthermore your team develop regulatory strategies for new and modified medical devices in different markets. You manage technical guidance and training to  the RA team and also cross-functional teams including training on procedures, FDA, MDR guidance documents, and international regulation. Your team take care of various regulatory documents e.g. such as Intended Use, Classification, Applicable Standards List, Essential Principles throughout the whole life cycle of the product. In relation to the needed documentation you need to review protocols and reports to support regulatory compliance. You and your team is in charge to write  submissions for new devices and device change notifications as required. You will also contribute to the further development of regulatory processes in the quality management system (QMS).

Depending on the regulations you may need to approve manufacturing changes for compliance with applicable regulations (Change Control) or device labeling for compliance with US, EU and International submissions and applicable regulations.

You will take responsibility for complex submission projects and ensure internal and external communication with regulatory partners of customers and suppliers, authorities and notified bodies. In general you also need to evaluate, document and communicate changes to authorities, customers and notified bodies and also interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as during audits to mitigate any potential risks.

Qualifications

You hold a degree in science or engineering (or comparable education) combined with a minimum of 4 years of experience and knowledge in the regulatory affairs for medical devices (drug-delivery devices, active and network-enabled medical devices advantageous).

Your experience in the registration of products in the USA, and EU (other markets desirable) and your excellent technical writing experience within a medical device environment will help make you very successful. It would also be an advantage if you have knowledge of software as a medical device (SaMD). Your strong verbal and written communication skills in English and German will keep up the momentum of the communication at multiple levels in the organization, with stakeholders and authorities.

You have very good leadership skills and also skills as a teamplayer. You are able to empower and motivate people to reach the goals and finding pro-active solutions.