Regulatory Manager

Floy; Frankfurt; Remote; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading company in medical AI seeks a talented individual to enhance product quality and regulatory compliance. You will engage in product development, drive certification processes, and shape operational excellence in a dynamic, fully remote environment. Join Floy and contribute to pioneering personalized health solutions with a focus on innovative AI technology.

Leistungen

Flexible remote team culture

Company retreats

Fair compensation

Weekly 1:1 feedback sessions

Qualifikationen

• Degree in a closely related field.
• Experience with regulatory affairs, specifically MDR & FDA.
• Ability to work in a dynamic, fully remote environment.

Aufgaben

• Manage product development consulting on regulatory matters.
• Shape process landscape and train employees.
• Facilitate medical device certification for international product compliance.

Kenntnisse

Regulatory Affairs

Business English

German

Communication Skills

Creative Thinking

Analytical Thinking

Fast Learning

Digitalization

Ausbildung

Bachelor / Master in Business Administration or Law

Jobbeschreibung

Your goal is to break the last barrier before go-to-market by ensuring outstanding product quality and continuous regulatory compliance. Your impact spreads at all levels of the organization and transforms mundane bureaucratic operations into efficient and delightful workflows.

YOUR RESPONSIBILITIES

• Bring our products overseas by paving the way towards an medical device certification.
• Directly engage in product development by consulting on regulatory matters and managing risks effectively.
• Shape our process landscape and train employees to achieve operational excellence.

WHAT ARE WE LOOKING FOR?

• Degree in closely related field - Bachelor / Master (e.g., Business Administration, Law, other)
• Business English and German (full proficiency)
• Outstanding written and verbal communication skills
• Experience with regulatory affairs (specifically MDR & FDA)
• Creative and analytical thinking
• Fast learning skills
• Strong affinity towards digitalisation
• Ability to work well in a dynamic, fully remote environment with an international team

Good-to-have :

• Independent and autonomous work style
• Experience in MedTech / SaaS / startup environment

We are looking for brilliant, hard-working people who strive to become recognised thought leaders in their domain. If you enjoy learning new things and thrive in a fast-paced environment, we would love to meet you. Together, we will continuously tailor the role to your strengths and development goals.

WHY US

Pioneer medical AI to maximize human health. Become part of an ambitious team valuing individuals, dedication and a joyful work experience. Solve novel challenges with life-saving implications.

• We accelerate your learning with rapid feedback, weekly 1 : 1 sessions and inspiring problems.
• We give you autonomy, flexibility and the opportunity to connect with our generation’s brightest minds.
• We provide flexible remote team culture, company retreats and fair compensation.

ABOUT US

Floy is on a mission to build the infrastructure for personalized health. Today, our AI products help radiologists to detect typically overlooked diseases. We envision a future where everybody can access annual holistic health assessments to prevent diseases through early detection.

Floy was founded in June 2021 and raised 8.8m€ total funding from Europe’s leading investors. Over the last months, the team grew to 50 exceptional people. Our pace only accelerates from here.