Tenovi is hiring a Quality & Regulatory Specialist to run the day-to-day work of our quality system and keep our devices, labels and FDA listings compliant. This is a full-time individual contributor role.

Our regulatory advisor designs and updates the quality system to meet FDA's Quality Management System Regulation (QMSR). You make sure it works in practice: you roll out procedures, train staff and keep records current. You also own routine regulatory upkeep and the hardware quality checks that follow an established SOP, such as receiving inspection and quarantine release. Test work that needs close back-and-forth with engineering stays with our Product Quality Specialist.

Responsibilities: quality system implementation and training

• Roll out the procedures, forms and tools developed with our regulatory advisor, and confirm teams follow them in daily work.
• Train employees on new and revised procedures, keep training records, and track completion.
• Run document control: versioning, review, approval, distribution and retirement of controlled documents and records.
• Support quality processes such as nonconformances, CAPAs, complaint handling and supplier controls. That means gathering records, tracking actions to closure and flagging anything overdue.
• Keep records ready for internal audits, customer audits and FDA inspections, and support the audits themselves.
• Report gaps between written procedures and how work actually happens, and propose practical fixes to the regulatory advisor.

Responsibilities: regulatory listings, labeling and packaging

• Keep FDA establishment registration and device listings current in FDA's FURLS system, including the annual registration renewal (October 1 to December 31).
• Manage GS1 identifiers: assign GTINs to new products and packaging levels, and keep product data accurate.
• Submit and maintain device identifier records in FDA's GUDID database.
• Update product labels, instructions for use and packaging artwork. Check them against FDA labeling rules (21 CFR Part 801), UDI rules (21 CFR Part 830) and other required markings, such as FCC, battery and country of origin.
• Run label change control: route changes for approval, check printed labels against approved artwork, and retire obsolete label stock.
• Watch for regulatory changes that affect labeling or packaging, and raise them with the regulatory advisor.

Responsibilities: hardware quality control

• Run receiving inspection on incoming inventory by following established SOPs, including sampling, visual checks, functional tests and documentation.
• Manage quarantine status: release or reject lots based on inspection results, and open a nonconformance for any failure.
• Coordinate with operations so held and released inventory is clearly marked and tracked.
• Pass issues that fall outside an existing SOP to the Product Quality Specialist or engineering. Help turn recurring tasks into new SOPs once the process is settled.

Qualifications

Required

• Bachelor's degree in a technical or scientific field, or equivalent work experience.
• 2 to 4 years in quality assurance, quality control or regulatory work for medical devices or another regulated industry.
• Working knowledge of FDA quality system requirements (21 CFR Part 820 / QMSR) and ISO 13485.
• Experience with document control and training records.
• Hands-on inspection or test experience with electronic products, and the discipline to follow procedures exactly.
• Clear writing, close attention to detail, and the confidence to train colleagues and hold them to procedures.

Preferred

• Experience with FDA FURLS, GUDID or GS1 product data.
• Experience with electronic quality management system (eQMS) software.
• Background with connected or remote patient monitoring devices.
• ASQ certification (such as CQIA, CQT or CQA) or Regulatory Affairs Certification (RAC).
• Experience at a small or fast-growing company.