FDA Compliance Specialist
Core
Ensures division compliance with Food, Drug, and Device regulations by partnering with Quality, auditing facilities, and representing the company during FDA inspections.
Role type
FDA Compliance Specialist (Quality & Regulatory)
Builds
Quality and FDA Compliance strategies, policies, standards, and optimized practices for food, drug, and device manufacturing.
Domain
Industrial and medical gases (oxygen, nitrogen, CO2) manufacturing and distribution
Required skills
FDA compliance auditing, cGMP knowledge, industrial/medical gas processes, regulatory law interpretation, corrective action management, audit representation, validation protocol review, deviation request creation, complaint investigation
Preferred skills
College degree, GXP/FDA controlled environment experience, multi-state distribution experience
Technologies
Microsoft Word, Excel, PowerPoint, Google Suites
Responsibilities
Partner with Quality Department on compliance auditing and regulatory assistance; Provide specialized guidance on Federal and State requirements for drug, device, and food products; Develop partnerships with operations and sales leadership to implement compliance strategies; Train local Quality Control Units on cGMPs; Perform physical and paper audits of manufacturing facilities; Represent company during on-site FDA and customer inspections; Review and approve validation protocols; Draft corrective action responses for audits; Coordinate investigation of serious medical complaints; Ensure procedural revisions are communicated and training is conducted.
Seniority
Mid-level, hands-on IC
