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Associate Manager, Regulatory AffairsOlympus - Center Valley, PACenter Valley, PA - The Associate Manager, Regulatory Affairs will be responsible for the regulatory program for product introduction, ensuring that all Scientific Equipment Group (SEG) products are compliant with Food and Drug Administration laws and regulations for medical device clinical evaluation, regulatory clearance, and distribution. The incumbent will also maintain the overall compliance program for medical device labeling for the SEG Group. EOE M/F/D/V * Interact with Manufacturing Business Centers (M-BCs) to ensure smooth and timely product introductions complying with all existing FDA regulations, such as 510(k) and IDE. Assist M-BC in the preparation and submission of premarket notifications [510(k)] for domestic distribution of medical devices. Counsel M-BCs regarding... See job listing >30+ days ago from Olympus - Save - Block - Flag - More Tools...
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Olympus
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Headquarters:
2 Corporate Center Dr
Melville, NY 11747
Phone: 631-844-5000
- Line of Business: Whol Medical/hospital Equipt Whol Photo Equip/supplies
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Key Numbers:
Company Type Private Company Revenue $100M - $500M Company Size 1000 - 5000 employees -
Job Location:
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