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WaveCrest Staffing Group · Chicago, Illinois
Senior Director, Regulatory Affairs
Schedule : Monday to Friday, 8am to 5pm
Hybrid in Cleveland, OH, with on-site presence one week per month. Relocation assistance may be available if needed.
Overview
Our client is a growing diagnostics company developing blood-based tests for early disease detection. They are seeking a Senior Director of Regulatory Affairs to set regulatory direction and lead execution for a portfolio of in vitro diagnostic and laboratory-developed tests. This leader will own regulatory strategy across the full product lifecycle, from pre-market submissions through post-market compliance, for both U.S. and international markets.
Key
Strategy and Leadership
Define and execute regulatory strategies for new and existing diagnostic products
Advise executives and cross-functional partners on pathways, risks, timelines, and business impact
Anticipate regulatory risks and put mitigation plans in place to protect development and launch timelines
Submissions and Agency Interaction
Lead planning, authoring, review, and filing of FDA submissions, including PMA, PMA supplements, 510(k), amendments, and annual reports
Oversee international technical documentation, including IVDR
Lead or support interactions with FDA, Notified Bodies, and other authorities, including pre-submission meetings and deficiency responses
Provide senior review of technical, clinical, analytical, manufacturing, and labeling documents for accuracy and consistency
Lifecycle and Change Management
Assess regulatory impact of design, manufacturing, process, labeling, and clinical changes
Maintain approvals, registrations, and related records globally
Post-Market Compliance
Lead post-market surveillance, vigilance reporting, adverse event assessment, and field action support
Support complaints, CAPA, audits, and inspections
Track evolving regulations, guidance, and enforcement trends and communicate implications to the business
Organizational Leadership
Build, mentor, and manage regulatory staff, consultants, and vendors
Establish roles, timelines, and accountability across internal and external teams
Develop regulatory procedures, templates, and document control standards that support inspection readiness
10+ years of progressive regulatory affairs experience in medical device, diagnostics, or IVD
Demonstrated leadership of FDA submissions, including PMA, PMA supplements, 510(k), pre-submissions, and responses to FDA questions
Working knowledge of FDA device and IVD regulations, QMSR, ISO 13485, CLIA, IVDR, and relevant guidance
Strong strategic judgment and the ability to advise executive leadership
Ability to manage multiple complex programs, budgets, and KPIs
Ability to maintain confidentiality of sensitive clinical, regulatory, and business information
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
Details
| Company | WaveCrest Staffing Group |
| Location | Chicago, Illinois |
| Type | FULL TIME |
| Niche | Full-time |
| Salary | $1,60,000 – $1,60,000 / yr |