Regulatory Affairs Specialist

vor 1 Monat

Berlin, Berlin, Deutschland Olympus Vollzeit
Job Title: Regulatory Affairs Manager

As a key member of the Olympus team, the Regulatory Affairs Manager plays a vital role in ensuring the company's products comply with international regulations. This includes providing regulatory guidance, supporting product launch compliance, and maintaining expertise in evolving industry standards.

Key Responsibilities:
  • Ensure Olympus products comply with regulatory requirements for key markets, including the US, EU, Japan, and others.
  • 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.
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

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