Regulatory Affairs Manager Wearable Devices (Full Time) Munich, Germany

Munich - Germany

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

NOXON is a Munich based MedTech startup founded in 2022 with the vision to transform muscle health on every skin. Guided by our purpose moving what matters we build technology that improves lives.

We are building a non-invasive muscle-computer-interface: a medical wearable that translates muscle signals into meaningful movement guidance.

At NOXON we believe in ownership. We believe in logic and strong partnerships over perceived limits. We believe that extraordinary results come from people who are willing to go the extra mile.

Tasks

Job Description

We are hiring a full time Regulatory Affairs Manager with strong business judgement to shape and implement the regulatory strategy for our medical products. You will own regulatory strategy and execution designing approval pathways that enable efficient market entry and scalable growth while maintaining full regulatory compliance.

As our products combine hardware and software your regulatory decisions will directly shape our products success and market close collaboration with management and R&D you will align regulatory strategy with product design and business priorities directly influencing key decisions that shape how we design certify and scale our medical products.

Your Main Tasks

- Define and drive the regulatory strategy designing approval pathways that enable efficient market entry and scalable expansion of our medical products

- Lead full lifecycle regulatory activities translating requirements into clear product constraints and submission-ready documentation including clinical evaluation PMS/PMCF notified body interactions and ongoing compliance

- Structure regulatory pathways to support future product iterations and portfolio expansion

- Partner with management on regulatory risk assessment and market access decisions

Requirements

Must-Have Qualifications

- Proven experience contributing to the design and execution of regulatory pathway strategies for software and hardware based medical systems (e.g. device classification conformity assessment routes)

- Experience in full lifecycle regulatory management including technical documentation clinical evaluation PMS/PMCF and lifecycle compliance

- Ability to translate regulatory requirements into pragmatic product and business decisions

- Exposure to regulatory strategy across product iterations or multiple product developments

Nice-to-Have Qualifications

- Experience in digital health data-driven or AI-enabled medical products

Benefits

What you get

- Real ownership with direct strategic impact on product design and market access

- Play a decisive role in bringing innovative medical products to market and improving peoples lives

- Culture with an ambitious team where your contribution is visible and valued

- Trust-based working hours and offices where you can shape your own workspace

- Clear opportunity to grow into a long-term regulatory leadership role as the we scale

What sets you apart
- You thrive in an environment where you take responsibility for quality and reliability of your outcomes
- You combine focus drive and energy with a strong commitment to delivering high-quality results
- You see the regulatory landscape not as a limitation but as a strategic design space
- You combine regulatory rigor with entrepreneurial thinking
- You understand the business impact of regulatory decisions on timelines resource allocation and product scalability

How to apply

Are we a match If you bring high passion talent and the ambition to perform at a high-level we will meet you at the extra mile. Send us your CV and further information to your previous work.

Tech Stack and Domain: regulatory strategy regulatory submissions technical documentation clinical evaluation PMS PMCF notified body market access digital health wearable devices medical devices
Related roles: Regulatory Affairs Specialist Senior Regulatory Affairs Manager Regulatory Affairs Lead Regulatory Compliance Manager

NOXON is a Munich based MedTech startup founded in 2022 with the vision to transform muscle health on every skin. Guided by our purpose moving what matters we build technology that improves lives.We are building a non-invasive muscle-computer-interface: a medical wearable that translates muscle si...