Regulatory Affairs Principal

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Responsible for managing tasks/processes and providing expert guidance on activities related to the design, development, and clearance of new products and product modifications. Will ensure that new products and documentation related to new product design, development, transfer, validation/verification, labeling, and regulatory submissions are compliant with applicable quality and regulatory requirements. Serves as the department expert and advisor on specialized activities such as Pre-Submissions, 510(k) submissions, PMAs, combination device applications and post-clearance activities and projects.

Provide guidance and participate in drafting of regulatory submissions for domestic, world-wide commercialization and other business objectives.
• Authors and reviews technical protocols and data in support of clinical trials, validation, verification and regulatory submissions.
• Provides guidance and participates in evaluation of the regulatory impact of changes associated with product design changes and routine modifications to cleared products.
• Reviews, and helps provide guidance for product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
• Provides guidance and participates in implementation of new regulations and standards.
• Conducts training of new employees, reviews training documentation for co-workers to ensure compliance to regulations.
• Other duties as assigned.

• Bachelor of Science degree in Biology, Biochemistry, Microbiology, Regulatory Affairs or related field.
• At least 7 years of experience in the medical devices industry; experience regarding medical device design, development, and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the IVD Directive 98/79 EC, as well as ISO 13485 requirements.
• At least 7 years' experience supporting medical device regulatory submissions (e.g., 510(k)s and/or PMAs); proven experience with application of quality and regulatory requirements in the design and development of medical devices.
• Professional certification (RAC/ASQ) required.
• Demonstrated success in achieving FDA and other regulatory agency approvals and clearances.
• Demonstrated knowledge of FDA regulations, In Vitro Device Directive and other national and international regulations and standards.
• 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.
• Knowledge of use of inspection tools and analytical processes.
• General knowledge of statistical analysis.
• Travel: 0-10%

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*