Senior Manager (m/f/d) Regulatory Intelligence
- 4516
- Medizintechnik
- Festanstellung
- 15.04.23
- Vor Ort
- Hamburg
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Medizintechnik
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Festanstellung
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Regulatory Affairs
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Perform regular monitoring laws and regulations with a focus on environmental-related regulation
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Identify potential regulatory intelligence which may impact Olympus’ product portfolio
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Develop and implement regulatory required processes
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Aggregate identified regulatory intelligence and perform quality checks to confirm that information is accurate
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Perform impact assessments on intelligence provided before sharing with other stakeholders (internal and external to Regulatory Affairs) to ensure intelligence is relevant and it is clear how this will impact Olympus’ portfolio and operations
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Monitor the internal implementation status of changes required by new regulatory requirements based on regulatory intelligence
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Partner with global RA functions to ensure new regulatory requirements are collected and analyzed
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Drive quality mindset to reinforce the corporate brand and become a trusted, collaborative and preferred business partner across Olympus
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Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International)
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Scientific degree in Chemistry advantageous
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Long-standing experience in regulatory affairs with specific experience in environmental regulations
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Experience in standardization work and interpretation of technical standards in the product portfolio of Olympus appreciated
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Regulatory project management support experience
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Experience supporting significant parts of the end-to-end product lifecycle management activities
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Experience authoring and or managing a range of global regulatory submissions (e.g., 510(k), CE Mark, etc.)
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Experience managing and operating QMS processes and systems
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Experience in working globally with understanding of global process flows and teaming
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Strong IT skills, experience utilizing a relevant regulatory system (ideally RIM/PLM), QMS systems and basic Office
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Good management of working relationships within Regulatory Affairs and with other internal departments (R&D, Manufacturing, Supply Chain, Quality, etc.)
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Strong written and verbal communication skills in an international environment
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