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Responsibilities:
- Providing guidance and participating in drafting of regulatory submissions for domestic, world-wide commercialization and other business objectives.
- Authoring and reviewing technical protocols and data in support of clinical trials, validation, verification and regulatory submissions.
- Providing guidance and participating in evaluation of the regulatory impact of changes associated with product design changes.
Qualifications:
- Bachelor of Science degree in Biology, Biochemistry, Microbiology, Regulatory Affairs or related field.
- At least 7 years of experience in the medical devices industry.
- Demonstrated knowledge of FDA regulations, In Vitro Device Directive and other national and international regulations and standards.
Skills:
- Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
- Understanding of FDA, EU, MDSAP and ISO standards applicable to the department and consequences of non-conformance.
- Computer proficiency required, including Word, Excel and database management.
Meridian Bioscience, Inc.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity.