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Acon Laboratory, Inc. Work Values
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Daily Duties at Acon Laboratory, Inc.:
Responsible for coordinate the accumulation of technical information for design dossiers and technical files for CE Marking. Prepare 510(k) submissions files and Canadian Device Licensing, review and approve CE labeling through internal review process. • Track and coordinate submission and review of design dossier and technical files in support of FDA and EU regulatory filings. • Process interface agreements with OEM customers to ensure compliance with FDA, QSR, IVDD and MDD requirements. • Represent Reguatory in review and approval of labeling bearing FDA 510(k) and CE Mark for ACON and variant brand products. • Responsible for the periodical update of FDA 510(k) cleared and CE marked product lists. • Interface with internal/external auditors in accordance with third party investigations to the Qualtiy System Requirements and compliance issues. • Assist in maintenance activities for company licenses, permits, etc. • Maintain proficiency on regulatory requirements and develop and maintain rapport with regulatory reviewers and project team members.
What they like about Acon Laboratory, Inc.:
Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.
Skills
Information about Acon Laboratory, Inc.
Company Rank: Not Available
Average length of employment : 0 years
Average salary of employees: $70,000
These are some of the questions we asked our climbers about their experiences with Acon Laboratory, Inc.:
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| Were your performance expectations clearly communicated? | 0.0 |
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| Were you recognized for meeting or exceeding expectations? | 0.0 |
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| Did you feel like your personal contribution was important? | 0.0 |
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| Was your career path clearly outlined and discussed? | 0.0 |
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| I would recommend this as a place of employment. | 0.0 | |
| I believe in the purpose of this organization. | 0.0 | |
| I would work for this organization again. | 0.0 | |
| I feel employees are fairly compensated. | 0.0 |
