Senior Regulatory Affairs Specialist

Client: Direct Client

Location: West Chester, PA

Job Title: Senior Regulatory Affairs Specialist

Duration: 1 year + (Possible Extension)

Job Summary:

The Recall Regulatory Specialist III will be responsible for leading OUS (outside the US) field action execution activities including managing Field Action Strategy Team meetings, coordinating and preparing document packages to notify regulatory agencies of field action activities, drafting internal and external customer communications, providing updates to FDA and global regulatory agencies, processing and closing Field Actions in a timely manner, and act as support for FDA and regulatory inspections.

Responsibilities:

• Working knowledge of 21 CFR Part 820, QSR, ISO 13485, CFR 806, and MDD/IVDD requirements is preferred. 

• The ability to work autonomously and on multiple projects with accelerated timelines is required. 

• Proven experience leading projects with cross-functional teams is required. 

• Proven ability to meet timelines is required. 

• Excellent Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc. is preferred. 

• Excellent computer (e.g., PowerPoint, WORD, Excel, Vision) communication, and written skills are required.