Sensile Medical Ag
Sensile Medical Ag Zürich Switzerland
2 months ago
We are hiring a remarkable Senior Regulatory Affairs Manager (m/f/d) to join our awesome team at Sensile Medical AG in Olten SO.
Growing your career as a Full Time Senior Regulatory Affairs Manager (m/f/d) is an awesome opportunity to develop relevant skills.
If you are strong in decision-making, cooperation and have the right personality for the job, then apply for the position of Senior Regulatory Affairs Manager (m/f/d) at Sensile Medical AG today!
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 of digital health products, particularly standalone software medical... devices, from the feasibility phase to the timely approval of products in international markets
• Close collaboration with the digital team, as well as R&D, Product Management, Medical Affairs and Quality
• Preparation of regulatory strategies for the approval of products in different markets
• Determination applicable registration requirements for standalone software medical devices, in all countries in which the products are to be registered
• Preparation and maintenance of regulatory documents such as intended use, classification, list of applicable regulations and standards, essential principles
• Review of deliverables from other disciplines
• Preparation of regulatory submission files
• Collaboration with regulatory partners at customers and suppliers, authorities, and conformity assessment bodies
• Approval of products worldwide; recertification of products
• Assessment, documentation, and communication of changes to authorities and conformity assessment bodies
• Representation of regulatory interests 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 connected medical devices and apps (software as a medical device [SaMD]), drug-delivery devices would be an advantage
• Experience in the submission and approval of products in the US, Canada and EU (further markets desirable), particularly for standalone software medical devices
• Knowledge and experience in addressing requirements for Digital Therapeutics (DTx), artificial intelligence/machine learning (AI/ML) and cybersecurity would be an advantage
• 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 English (German would be an advantage)
We offer a challenging, international environment and the opportunity to actively contribute to the company and different teams with knowledge and engagement, and to develop personally. We also offer a modern workplace in a historic building, advanced and flexible working conditions as well as salaries according to performance and well-developed social benefits.
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 Mr. René Ziegler, Senior Recruiting Specialist, Telefonnummer auf myjob.ch ansehen
Benefits of working as a Senior Regulatory Affairs Manager (m/f/d) in Olten SO:
● Learning opportunities
● Company offers career progression opportunities
● Advantageous package
Senior Regulatory Affairs Manager /m/f/d/ - Urgent Hire Zürich jobs
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