Regulatory Affairs Manager (m/f/d)

As a listed MDAX company, Gerresheimer is a leading global partner to the healthcare and cosmetics industries. We generate sales of around 1.4 billion euros and are represented worldwide with about 10,000 employees.

Sensile Medical, part of the Gerresheimer Group, is a dynamic company specialized in the development of wearable medical devices for liquid drug delivery. We work daily to improve the quality of life of patients worldwide.

• Accompanying development projects from the feasibility phase to the timely approval of products in international markets
• Preparation of regulatory strategies for the approval of products in different markets
• Collaboration with the disciplines R&D, Product Management, Medical Affairs, Industrialization and Quality
• Preparation and maintenance of regulatory documents such as intended use, classification, list of applicable regulations and standards, essential principles
• Collaboration with regulatory partners at customers and suppliers, authorities and conformity assessment bodies
• Registration of products worldwide; recertifications of products
• Approval of products worldwide; recertification of products
• Assessment, documentation and communication of changes to authorities and conformity assessment bodies
• Representation of regulatory requirements in the company (MDR, US and global requirements)
• Supporting further development of regulatory processes in the quality management system

• Successfully completed scientific or engineering studies (or comparable education)
• Profound experience and knowledge in Regulatory Affairs for medical devices (drug-delivery devices, active and connected medical devices would be an advantage)
• Experience in the approval of products in the US, Canada and EU (further markets desirable)
• Pleasure in goal-oriented writing and reviewing of documents
• Systematic, quality-oriented and well-documented working method
• Team player with strong analytical skills who is proactive and solution-oriented
• Dedication and excellent communication skills
• Fluency in German and English

We are on an exciting journey as we take an active role in creating the future of the digital healthcare ecosystem. In this role you take a leading role for the use of Web Technologies. If you have a solid experience in developing Web Application, you want to change the way chronic diseases are managed and you are looking for a place where you get the freedom to creatively contribute the future of healthcare, we look forward to getting to know you in person.

Interested? Please upload your complete application (letter of motivation, CV, job references, diplomas / certificates) by clicking on the "apply now" button. We look forward to reading from you.

Your contact person -For further information please contact Diana Schulthess, Human Resources Assistant, +41 62 209 71 00