Manager Research Regulatory Affairs Innovate and Research

Kettering Health

Kettering, OHFull-time

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Qualifications

  • •You'll need a minimum of 4 years of progressive experience in clinical research, with demonstrated involvement in FDA-regulated research
  • •Hands-on experience with industry-sponsored clinical trials covering both drugs and devices is required
  • •You should possess in-depth knowledge of FDA regulations, ICH
  • •GCP E6(R3), and clinical research compliance requirements
  • •Proficiency with electronic regulatory systems, CTMS platforms, and delegation of authority management is essential
  • •Your proven ability to maintain audit-ready regulatory documentation and effectively support audits and inspections will be a key asset
  • •You'll need strong organizational, analytical, written, and verbal communication skills, with the capacity to manage multiple studies and regulatory priorities simultaneously across various therapeutic areas
  • •Experience developing institutional regulatory infrastructure, SOPs, templates, and training programs is highly valued
  • •5 more items(s)

Responsibilities

  • •You'll be the primary point of contact between Kettering Health and external regulatory agencies, including IRBs, the FDA, sponsors, and monitors
  • •Your work will directly ensure that all clinical trials—whether industry-sponsored, investigator-initiated, or physician-held INDs—maintain the highest standards of regulatory compliance
  • •Your responsibilities include preparing, reviewing, and submitting regulatory documents such as IRB submissions, FDA filings, IND and IDE applications, protocol amendments, annual reports, and safety reports
  • •You'll develop and implement regulatory standard operating procedures, workflows, templates, and processes to create consistency across all studies
  • •Beyond day-to-day compliance, you'll provide strategic regulatory guidance on industry-sponsored trials, investigator-initiated studies, and device studies
  • •You'll also support and expand our institutional capability for physicians to serve as IND or IDE sponsors, offering guidance on FDA submissions, correspondence, and ongoing compliance obligations
  • •Maintaining audit-ready status is critical
  • •You'll be responsible for keeping regulatory files current and complete—including delegation of authority logs, protocol signatures, investigator agreements, and essential documents
  • •You'll lead preparation for internal audits, sponsor audits, and regulatory inspections, ensuring we're always inspection-ready
  • •You'll also manage regulatory and research training requirements for all study personnel, including CITI certification, GCP training, FDA-required training, and device or IND-specific training
  • •Electronic regulatory systems, Clinical Trial Management Systems (CTMS), and other compliance tracking tools will be key parts of your daily workflow
  • •Collaboration is essential—you'll work closely with principal investigators, clinical research staff, legal and compliance partners, and sponsors throughout the entire study lifecycle
  • •Staying current on FDA regulations, guidance documents, ICH
  • •GCP E6(R3) standards, and emerging regulatory trends will be part of your ongoing professional responsibility
  • •11 more items(s)
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