Regulatory Affairs Manager (m/f/d) Digital Products/ Software

OLYMPUS EUROPA SE & CO. KG
Berlin, Hamburg
EUR 80.000 - 100.000
Jobbeschreibung

Regulatory Affairs Manager (m/f/d) Digital Products/ Software

Olympus Winter & Ibe GmbH (OWI) | Medical Systems | from 01.12.2024, fulltime, unlimited contract

The Regulatory Affairs Manager ensures compliance of Digital Unit (DU) products with international regulations, provides regulatory guidance, supports product launch compliance, and maintains expertise in evolving industry standards. Your Key Responsibilities:

  • Ensure DU products comply with regulatory requirements for US, EU, Japan, and key markets.
  • Provide regulatory oversight and guidance to development teams, focusing on AI, Software as a Medical Device (SaMD), and Machine Learning.
  • Support compliance for launched products with Olympus Regulatory Affairs.
  • Respond to regulatory body inquiries and manage communications with international agencies.
  • Maintain expert knowledge of relevant regulations and assess the impact of legislative changes.
  • Collaborate with stakeholders to develop strategies that address regulatory updates and ensure compliance.
  • Manage third-party vendors as required.
  • Collaborate with cross-functional teams to drive regulatory strategy and innovation.

Minimum Requirements:

  • University degree in relevant fields with 2+ years of Regulatory Affairs experience in the medical device industry.
  • Expertise in SaMD, Class I/II/III medical devices, and AI/ML-enabled technologies.
  • Experience with international regulators (FDA, Notified Bodies) and agile development teams.
  • Strong ability to align digital, business, and R&D leadership on regulatory needs.
  • Collaborative mindset, excited to work with cross-functional teams and embrace change.
  • Comfortable challenging the status quo and providing strategic direction.
  • Excellent problem-solving, communication, and English language skills (written and verbal).

Benefits:

  • 30 days of annual leave
  • Up to 60% mobile work possible + flexible work time model with overtime compensation
  • Holiday and Christmas bonuses
  • Corporate benefits discounts for employees
  • Comprehensive company pension scheme and capital-forming benefits
  • Company restaurant with live cooking and healthy food (subsidized)
  • Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
  • Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
  • Various subsidized company sports groups and access to the inhouse company gym

About Olympus Medical Systems

The Medical Systems Division represents Olympus’ largest business domain and is the global market and technology leader for medical endoscopes. Olympus aims to continuously find better and more economical solutions to medical issues which improve the well-being of patients, enhance the working environment for doctors and nursing staff and help to develop the overall performance of health care providers.

Further Information:

Valuing diverse perspectives and lifestyles is one of our core values. We would therefore like to encourage all people to apply – regardless of gender, restrictions, nationality, ethnic and social origin, religion, world view, age as well as sexual orientation and identity.

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