Regulatory Complaint Analyst, San Jose, CA
6 month-1 year contract (possibility for conversion)
* Reviewing and performing RA investigation for medical device complaints and determines the resolution of the complaint with occasional direction from Supervisor and/or senior staff.
* Determining if further inquiries are required with field resources(ESS, TT, Sales Rep or customer).
* Performing follow-up inquiry and documenting all communications in compliance with MSG good documentation practices and department procedures.
* Determining if a reported event classifies as a 'Medical Device Reportable' as defined by various regulatory agency.
* Filing proper documentation with applicable agencies as required.
* Preparing and submitting MDRs/Supplemental reports for review to Supervisor and/or senior staff in a timely manner.
* Communicating with Manufacturing Business Centers(MBCs) for failure investigation responses.
* Monitoring progress of all ongoing complaint investigations and MDRs to ensure the timely submission and closure of complaint files.
* Maintaining traceability, and manually and electronically document the applicable elements of the complaint handling process, such as contact records with the external customers, database update, and complaint closure letters.
* Improving the complaint handling process for better efficiency and greater integrity.
* Entering complaint and investigation related information in the database.
* Coordinating MDR investigations with Infection Control staff.
* Monitoring and tracking progress of any outside laboratory evaluation, when necessary.
* Conducting trend analysis of complaints and notifying Supervisor of critical changes.
* Preparing and submitting FDA Additional Information responses, and associated documentation to the FDA and Manufacturing Business Centers(MBCs).
* Following up with MBC or vendor, as required, for failure investigation responses.
* Assisting Regulatory Management in the successful identification and resolution of quality issues associated with complaints that require Regulatory Affairs investigation.
* Participating as a member of the internal audit team to ensure regulatory compliance.
* Performing all other related duties as assigned.
* Bachelor's Degree in scientific discipline or a High School Diploma/GED with a minimum of 3 years of complaint handling experience in medical device, a closely related field, and/or pharmaceutical industry or equivalent.
* Knowledge of Quality System Requirements (21 CFR 820 & 803).
* Ability to multitask and abilty to meet deadlines on multiple projects.
* Demonstrated ability to understand and comply with applicable FDA regulations and MSG operating procedures, processes,policies and rules is essential.
* Ability to maintain regular and predictable attendance.
* Strong analytical and organizational skills.
* Strong attention to detail and accuracy.
* Knowledge in medical terminology and human anatomy are desired.
* Ability to apply professional concepts and company policies and procedures, analyze data or situations, and exercise judgment to recommend solutions to solve problems.
* Ability to follow standard practices and procedures in analyzing situations or data from which answers can be obtained.
* Ability to read, write and communicate effectively in English which includes clear, understandable speech and demonstrated comprehension skills.
* Ability to collaborate and be a team player.
* Ability to demonstrate a working proficiency in operating a personal computer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications.
* Ability to demonstrate basic skills in punctuation, grammar, spelling and basic math.
* Ability to provide guidance to less experienced staff.
With Kelly, you'll have access to some of the world's highest-regarded scientific organizations— providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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