Regulatory Affairs Manager - Medical Devices - BaWu

Job Type
Emp Type
Full Time
Pharma & Health
Functional Expertise
Pharma/Biotech, Projektmanagement/Führungskräfte
Salary Type
Job ID

Job Description

Our client is a world leading Medical Devices Producer, for their HQ in BaWu (20 km from Konstanz) they're currently looking for a:

Regulatory Affairs Manager / Market Access Specialist


As a Regulatory Affairs Specialist, you'll be at the forefront of ensuring compliance and success in the medical device industry. Here's what you'll be doing and what we're looking for:


  • Regulatory Requirements Identification: You'll meticulously identify the regulatory requirements necessary for approval within your designated region.

  • Approval Strategy Development and Support: Crafting effective approval strategies and providing unwavering support throughout the approval process will be your forte.

  • Submission Document Preparation: You'll be tasked with preparing and providing the essential submission documents required for regulatory approval.

  • Strategic Project Input: Your insights will shape the strategic direction of assigned projects, contributing to their successful development.

  • Central Point of Contact: Acting as the primary liaison, you'll be the go-to person for our subsidiaries and partners, ensuring seamless communication and collaboration.

  • Normative Requirements Advisory and Monitoring: You'll provide valuable guidance on normative requirements, overseeing their adherence throughout the development process.

  • Internal Training Implementation: Taking charge of internal training initiatives, you'll ensure our team is well-equipped with the knowledge they need to excel.

  • Stakeholder Communication: Keeping stakeholders informed about approval changes, standards, and their implications on our products will be a top priority, enabling proactive decision-making.

Your Talents:

  • Educational Background: You hold a degree in scientific/technical studies or possess equivalent training, providing you with a solid foundation.

  • Experience: You bring invaluable experience in the realm of medical device approval, demonstrating your expertise in navigating regulatory landscapes.

  • Specialized Knowledge: Your initial expertise in medical devices positions you as a knowledgeable asset to our team.

  • Global Project Collaboration: You exude confidence in global project structures, seamlessly integrating and contributing to diverse teams.

  • Communication and Analytical Skills: Your strong communication and analytical prowess enable effective conveyance of complex regulatory information.

  • Independence and Structure: With your independent and structured approach, you'll adeptly manage tasks, ensuring efficiency and precision.

  • Language Proficiency: Your proficiency in both German and English facilitates seamless communication and collaboration within our global environment.