Regulatory Affairs Specialist
vor 4 Wochen
About the Role
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 product compliance with regulatory requirements, providing oversight and guidance to development teams, and maintaining expertise in evolving industry standards.
Key Responsibilities
- Ensure Digital Unit products comply with regulatory requirements for 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.
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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