Hi All,
One of my clients is looking Role: Regulatory Affairs Specialist, if you’re interested or your skills match, please send your updated resume to sohail@intellectt.com
Job Title: Regulatory Affairs Specialist
Location: Murrysville, PA
Position Summary:
We are seeking a Regulatory Affairs Specialist to support manufacturing line transfer activities. This role ensures compliance with regulatory standards and contributes to process improvement and validation.
Key Responsibilities:
- Ensure regulatory compliance during manufacturing line transfers.
- Support validation activities (Installation Qualification, Operational Qualification, Performance Qualification).
- Assist in preparing and reviewing regulatory documentation.
- Manage engineering change control processes.
- Identify and address Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
- Design and analyze trials using appropriate statistical methods.
Qualifications:
- Bachelor’s degree in Engineering, Regulatory Affairs, or a related field.
- 7+ years of experience in regulatory affairs, particularly in manufacturing line transfers.
- Strong understanding of validation activities and engineering change management.
