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Innovacon, Inc., A Division Of Inverness Medical Innovations Work Values
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Daily Duties at Innovacon, Inc., A Division Of Inverness Medical Innovations :
Responsible for coordinate the accumulation of technical information for design dossiers and technical files for CE Marking. • 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 Innovacon, Inc. and variant brand products. • Liaison to FDA, Notified Body and Authorized Representative O Interface with FDA reviewers and/or Notified Body through written and oral communication as needed. O Interface with Authorized Representative to ensure compliance with EU countries for CE Marking submission and negotiastions to ensure a timely approval. • Assist in maintenance activities for company licenses, permits, etc. including DEA activities. • Review proposed changes for Regulatory impact in change control board meetings (CCB)
What they like about Innovacon, Inc., A Division Of Inverness Medical Innovations :
Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.
Skills
Information about Innovacon, Inc., A Division Of Inverness Medical Innovations
Company Rank: Not Available
Average length of employment : 2 years
Average salary of employees: $70,000
These are some of the questions we asked our climbers about their experiences with Innovacon, Inc., A Division Of Inverness Medical Innovations :
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| Were your performance expectations clearly communicated? | 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 |
