ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Associate, Regulatory Affairs (ONSITE) on a permanent basis at Cincinnati, OH . Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! J ob Title: Senior Associate, Regulatory Affairs Employment Type: Full Time Location: Hybrid (Cincinnati, Ohio) - Location Address: 4545 Creek Rd Blue Ash, OH 45242 Responsible for managing, planning, preparation, and delivery of documents both electronic- and paper-based in support of assigned. global regulatory product registrations, renewals, tenders/customs, etc. Coordinate the preparation and submission of medical device applications by providing regulatory information and documents and following up closely on queries from inspection through approval. Prepare and/or review letters of authorization, cover letters for registration certificates, declarations, power of attorney, and other regulatory documentation to ensure accuracy, appropriateness, and consistency of documents intended for various global regulatory submissions. Submit and manage applications for the US FDA Certificates to Foreign Government (CFGs). Maintain various tracking tools to ensure up-to-date information and traceability of all regulatory data/documentation. Perform and/or coordinate legalization, notarization, and apostille of regulatory documents Ensure compliance with current good documentation practices, including but not limited to proofreading, formatting, indexing and recordkeeping. Assist all regions in answering inquiries and providing required documents and information utilizing various search tools and systems. Perform document filing and retrieval functions as directed and per company’s policies and pro
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Role overview
Job description
Hyliion is committed to creating innovative solutions that enable clean, flexible and affordable electricity production. The Company’s primary focus is to develop distributed power generators that can operate on various fuel sources to future-proof against an ever-changing energy economy. Job Purpose The Senior Supplier Quality Engineer owns the technical health of Hyliion's precision machining supply base and serves as the senior technical authority for machined content on the KARNO Power Module. Much of the machined content that determines whether a machine runs, including tolerances, surface finishes, form and runout requirements, and sealing surfaces, is produced by external partners, some of it on additively manufactured parts. This position sets the standard for how supplier quality is practiced at Hyliion, including the qualification evidence required, the inspection methods use
…What they are looking for
Skills & requirements
Qualification
This position sets the standard for how supplier quality is practiced at Hyliion, including the qualification evidence required, the inspection methods used, and the technical judgment applied when a part is borderline; Own first article inspection and part qualification, including AS9102-style FAI, dimensional layout, key characteristic definition, and a PPAP-style evidence set scaled to a low-volume, high-consequence environment; Build inspection and acceptance strategy, including inspection plans, key characteristics, sampling versus 100% inspection, source inspection and delegation decisions, certificates of conformance, material certification, and traceability; Qualifications include: Education, Experience and Certifications Bachelor's degree in engineering or a related technical discipline required, or equivalent demonstrated experience
Department · Operations
Hiring company
Hyliion
Hyliion's fuel flex linear generators deliver resilient, onsite power generation for data centers, microgrids, defense, & more.
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