MDR/Vigilance Specialist

Location: Irvine, California
Posted On: 7/6/2017
Job Code: 7460_MDR_CA_IR
Job Description
Position description:
This position provides communication and follow-up to customers and field sales force regarding the analysis results of customer complaints for Neurovascular products. Communicates event investigation results via regulatory reports and written communications, as appropriate.
This process is governed by the FDA Quality System Regulations (QSR) Guidelines, ISO 13485:2003, Good Manufacturing Practices (GMPs), and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations.
This position requires the individual to be a contributor to product quality improvement efforts and be the main contact to our customers on complaint issues. In addition, under supervision this position will analyze customer complaints to determine which are regulatory reportable, will generate and submit the regulatory reports within the government mandated timelines, and is a key contact for activities with internal, field, and end user customers.

Position responsibilities:
• Receive and document product events reported by customers and field representatives.
• Request additional information as needed for complete understanding of the event. Determine if event is a product complaint.
• Enter all information related to the events into the complaint database.
• Maintain complaint files that meet the QSR and Corporate requirements.
• Evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, company field representatives, internal employees, and laboratory analysis
• Facilitates complaint communications
• Assess for regulatory reportability and potential impact to patient safety and business operations with minimal supervision.
• Completes and submits regulatory reports within the timeframes mandated by the FDA with minimal supervision.
• Solid product knowledge in clinical settings related to product application
• Maintain technical knowledge of devices in area of responsibility.
• Perform other duties as assigned by manager.

Basic qualifications:
Broad knowledge in worldwide medical device or pharmaceutical complaint handling and regulatory reporting.

Required education:
Typically requires a University Degree or equivalent experience

Required years of experience:
1+ years

Required knowledge:
• FDA regulations (21 CFR 820, 803), ISO 13485, MEDDEV 2.12-1
• Knowledge of effective root cause investigation
• Broad knowledge in medical device, pharmaceutical and/or a comparable regulated environment.

Desired/Preferred Qualifications (optional)
• LPN, RN, CNP, BioMedical Engineer or Bachelor of Science degree
• Solid knowledge of worldwide adverse event reporting requirements (21 CFR 803, QSR 820, MEDDEV 2.12-1, Article 253 of Pharmaceutical Affairs Law, etc.).
• Solid understanding and application of business concepts and practices.
• Multi-task management and Effective priority setting
• Solid oral and written communication skills
• Record management
• Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
• Works under minimal supervision.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
Category:IT  code:new
Job Requirements
Complain handeling, word , Excel

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Contact Details
Sparsh Patel
E-mail Address