Regulatory Affairs Specialist
vor 3 Wochen
Key Responsibilities:
The Regulatory Affairs Manager at Olympus ensures compliance of Digital Unit products with international regulations, providing regulatory guidance and supporting product launch compliance. Key responsibilities include:
- Ensuring DU products comply with regulatory requirements for US, EU, Japan, and key markets.
- Providing regulatory oversight and guidance to development teams, focusing on AI, Software as a Medical Device (SaMD), and Machine Learning.
- Supporting compliance for launched products with Olympus Regulatory Affairs.
- Responding to regulatory body inquiries and managing communications with international agencies.
- Maintaining expert knowledge of relevant regulations and assessing the impact of legislative changes.
- Collaborating with stakeholders to develop strategies that address regulatory updates and ensure compliance.
- Managing third-party vendors as required.
- Collaborating 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:
Olympus offers a range of benefits, including:
- 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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