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Director of R & D Business Development
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$120,000
- Job Title: Regulatory Affairs SpecialistJob Responsibilities:This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.
- Represents regulatory affairs on product development and commercialization teams.
- Tracks timelines and documents milestone achievements for inclusion in regulatory submissions.
- Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files).
- Assists with customer complaints/CAPA system.
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