REGULATORY COMPLIANCE ASSOCIATE

POSITION RESPONSIBILITIES:

 

Reporting to the QA/RA Manager, the Regulatory Compliance Associate is responsible for GMP initiatives for FDA registered medical device production and associated process content review, control, and performance monitoring, with emphasis on Production & Process Controls.

?  Attend/participate New Product Introduction design & development meetings; create/review/approve device master records, quality control plans, engineering/production risk analysis, labeling, engineering verification & validation results, production process validation results, and engineering change orders for adequacy/compliance prior to device transfer to production.

?  Audit/create/review/approve/release production GMP documents/SOPs/work instructions, technical files/other European MDD documentation as required, ECOs and Batch Records during device manufacturing, and communicate necessary changes to applicable department representatives to maintain compliance.

?  Act as QA/RA department representative during R&D, Manufacturing Engineering, Manufacturing Cell meetings, communicate/review all applicable device adverse event report results, and coordinate corrective and preventive actions as required.

?  Review/approve requests for custom devices (SURFs) prior to releasing to manufacturing.

?  Assist QA/RA Manager in establishing, planning, and executing various regulatory compliance strategies for continuous improvement of regulatory systems.

?  Assist QA/RA Manager in 510k preparation and submission of FDA pre-market approvals/notifications and/or European Competent Authority international technical information/product registration for new products, as required.

 

Experience Required:

 

2 years industrial/electronics design and manufacturing environment; in either a quality, regulatory, design, or manufacturing role; within a medical device related company; or equivalent.

Quality auditor, regulatory investigator, or equivalent status with having performed internal process audits.

Problem root cause analysis, verification & validation, flow mapping, and organizational and time-management skills.

Ability to work cross-functionally with all levels of personnel.

Computer proficiency with emphasis on MS Office, Lotus, and SAP business information system.

 

Education Required:

 

BS in IE, Mfg Eng, Quality/Regulatory, or equivalent.