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:

Responsibilities:

• 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.