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Job Responsibilities:
- Provide support and guidance to quality and regulatory activities, including design control, project teams, and product modifications.
- Draft, evaluate, and review technical protocols and data for clinical trials, validation, and product manufacturing.
- Respond to Sales & Marketing requests to ensure promotional materials comply with regulations.
Qualifications:
- Bachelor of Science in Biology, Biochemistry, Microbiology, or related field required.
- Minimum 4 years of direct Regulatory Affairs experience, including preparation of Pre-IDEs, 510(k) applications, EU Technical Files, and Canadian licenses.
- Proven knowledge of FDA and ISO regulated environment for medical devices and in vitro diagnostics.
Skills & Attributes:
- Demonstrated strong leadership, project management, and organizational skills.
- Highly motivated with attention to detail, ability to prioritize workloads, and meet strict deadlines.
- Exceptional communication and interpersonal skills, ability to interact effectively with all levels.
Meridian Bioscience
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. The company is dedicated to developing better solutions for life from discovery to diagnosis and fosters an innovative culture for talented individuals to solve tough problems.