Regulatory Affairs Manager Medical Devices (f/m/d)

Our mandate is a Munich based start-up company with a patented, breakthrough technology for fluorescence image-guided surgery searches for a Regulatory Affairs Manager Medical Devices.

Being an independent part of an international market leader in diagnostic imaging, the company offers both features of working in a start-up atmosphere plus the security and financial backing of belonging to a peer international organization.

You will lead the worldwide regulatory submission processes and align with Program Management functions to support new product development, product launches, product life cycle management and corporate objectives

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Your tasks

• Development and implement project plans and regulatory roadmaps for defined devices
• Compile and update regulatory documents in accordance with FDA and EU requirements
• Plan, coordinate and complete applications for registrations and submissions and prepare responses to questions/findings
• Create and maintain internal regulatory file documentation
• Assess regulatory documents from third parties
• Prepare and conduct meetings with regulatory authorities
• Interact with authorities and notified bodies as needed on behalf
• Maintenance for registered products: Preparation and submissions of applications for changes, reports etc. in due time
• Establish a process for Regulatory Intelligence
• Lead or represent Regulatory Affairs in project teams
• Collaborate with Development, Clinical, Quality and Marketing on all aspects of the product life cycle
• Developing and updating regulatory related SOPs for Quality Management System and support QMS audits and inspections

Your profile

• Bachelor’s or Master’s degree in Engineering, Science, or equivalent discipline
• Several years medical device industry and regulatory experience with USA (510(k) and EU MDD/MDR, preferably with active medical devices
• Experience in creating and maintaining technical documentation
• Experience in communication with notified bodies and authorities
• Experience with quality systems regulations and guidelines such as QSR, ISO 13485
• Ability of interpreting legislation and impact to meet commercial needs
• Analytical thinking and highly structured way of working
• Ability to work independently but also a motivated and enthusiastic team player
• Hands-on mentality
• Excellent skills and experience with Microsoft Office (Outlook, Word, Power Point, Excel)
• Excellent written and verbal communication skills in English
• Ability to travel if needed

Your opportunity

• High level responsibility in an exciting and dynamic environment
• Fascinating challenge in high-end medical device technology
• Be a major part of a small team in an exciting industry
• Work in a start-up atmosphere with the background of an international market leader
• Attractive offices in München
• Additional benefits as insurances and pension fund
• Be part of the introduction of a breakthrough technology for tumor surgery