(Senior) Regulatory Affairs Expert (m/f/d)

Ebenbuild; Deutschland; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A technology start-up in Germany is seeking a Regulatory Affairs Specialist to join their team. In this role, you will develop regulatory strategies for FDA clearance and manage documentation for US and EU submissions. The ideal candidate has over 5 years of experience in regulatory affairs for medical devices, especially software products. This hybrid position offers flexibility and the chance to make a significant impact on patient lives.

Leistungen

Central office in the heart of Munich

Flexible work-from-home scheduling

Impactful products development

Leading role in innovative projects

Qualifikationen

• 5+ years of experience in regulatory affairs for medical devices.
• Proven success with FDA (510(k)/De Novo) and MDR Class II submissions.
• Strong knowledge of 21 CFR Part 860/807/812, FDA Guidance, MDR.

Aufgaben

• Develop and implement the regulatory strategy for FDA clearance.
• Create and maintain regulatory documentation for US/EU submissions.
• Coordinate RA-related work and resource allocation.
• Lead regulatory submissions and interact with authorities.

Kenntnisse

Regulatory strategy development

Regulatory documentation management

Knowledge of FDA regulations

Knowledge of MDR regulations

Excellent communication skills

Analytical skills

Ausbildung

Completed university education in a technical or scientific field

Jobbeschreibung

Your mission

We want you to join our early-stage university spin-off that has just received its ISO 13485 certification. As an integral part of our team, you will harness your regulatory expertise to ...

• ... develop and implement the regulatory strategy for FDA clearance (De Novo) and conformity assessment under MDR (class II).
• ... create, manage, and maintain regulatory documentation for US and EU submissions.
• ...provide Regulatory Affairs expertise to support development and change initiatives.
• ... coordinate the scheduling and planning of RA-related work and resource allocation.
• ... plan and contribute to clinical evaluation activities, including CEP/CER and post-market surveillance.
• ... lead regulatory submissions and interactions with authorities for our SaMD product in an evolving software and machine learning regulatory landscape.
• ... collaborate cross-functionally with QA, product, clinical, and engineering teams to ensure regulatory alignment.

Your profile

• Completed university education in a technical, scientific, or comparable field of study.
• 5+ years of experience in regulatory affairs for medical devices, with a focus on software products (SaMD).
• Proven success with FDA (510(k)/De Novo) and MDR Class II submissions.
• Strong knowledge of 21 CFR Part 860/807/812, FDA Guidance, MDR, and clinical evaluation processes
• Strong analytical skills combined with creativity and intuition.Excellent written and verbal communication skills in English. German is a plus.
• Independent and solution-oriented approach to work.
• Hands-on, structured, and comfortable working in a dynamic startup environment.

Why us?

• Central office in the heart of Munich
• Hybrid role with flexible work-from-home scheduling
• Build products that will have a measurable impact on the lives of patients
• Play a leading role in shaping the path to the market for a highly innovative software product
• We are an interdisciplinary team of highly motivated, skilled, and ambitious people. Individual contributions count...a lot!