Knoxville Categories:
VP QUALITY ASSURANCE / REGULATORY AFFAIRS (QA/RA) ABT Molecular
Job DescriptionABT Molecular Imaging, Inc. ABT has developed an
exciting product for the medical and biotechnology industries. The
PET Biomarker Generator is designed to produce on-demand access
to all significant F-18 and C-11 PET biomarkers to imaging
providers.
Vice President, Quality and Regulatory Affairs Description: Lead
the quality and regulatory affairs effort as a member of the Senior
Executive team
Responsibilities/Duties:
Developing and implementing the Company's device and drug registration strategy
Liaison to US and international device and drug registration agencies
Develop, Implement and maintain the Company's environmental, health and safety policies and procedures
Oversight of the radiation safety policies, procedures and program. Serve as Radiation Safety Officer (RSO)
Establish US and International product and manufacturing certifications
Interact with customers and their respective technical and regulatory experts
Qualifications:
A minimum of a bachelor?s degree in science or engineering field. Advanced degree a plus.
5 - 7 years of senior leadership experience in a drug or device company
Experience interacting directly with the US and International Regulatory Agencies
Prior experience with Drug Registrations and Medical Device filings
Strong knowledge of ISO quality standards and oversight of quality system
Strong knowledge of US and International PET Radiopharmaceutical cGMP Regulations
Strong ability to work cross functionally with all departments in the organization
Knowledge of CE Mark process is a plus
| Location: | Knoxville, TN United States |
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ABT Molecular
Investors: River Cities Capital FundsAll Jobs: at ABT Molecular
| Web Site: | advancedbiomarker.com/ |
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| Headquarters: | 00000 United States |
