What are the responsibilities and job description for the Regulatory Affairs Specialist (Medical Device) position at TekOne IT Services Pvt. Ltd.?
Role: Regulatory Affairs Specialist
Location: Morrisville, PA
Type: Long Term Contract
Experience: 7 years of experience in regulatory affairs with specific expertise in manufacturing line transfers.
Job Duties
Regulatory Affairs Specialist:
Location: Morrisville, PA
Type: Long Term Contract
Experience: 7 years of experience in regulatory affairs with specific expertise in manufacturing line transfers.
Job Duties
- Support Manufacturing Line Transfer Activities: Ensure regulatory compliance during the line transfer process.
- Quality Documentation: Assist in preparing and reviewing regulatory documents to ensure proper alignment with relevant regulatory standards.
- Validation Activities: Participate in validation efforts such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) related to the line transfer process.
- Trials and Statistical Techniques: Assist in the design and analysis of trials and validation using appropriate statistical methods.
- Control Variables: Ensure that appropriate control variables are identified, measured, and managed during validation and line transfer processes.
- Engineering Change Management: Support engineering change control processes, including the creation and management of engineering documents.
- NCRs and CAPAs: Assist in identifying and addressing Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs) as required.
Regulatory Affairs Specialist:
- Bachelor’s degree in a relevant field (Engineering, Regulatory Affairs, or similar).
- 7 years of experience in regulatory affairs with a focus on manufacturing line transfers.
- Strong understanding of validation activities including IQ, OQ, and PQ.
- Experience with engineering change management and document control.
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