1+ months

Regulatory Compliant Analyst

Kelly Services
San Jose, CA 95115
**Regulatory Complaint Analyst, San Jose, CA**

**6 month-1 year contract (possibility for conversion)**

**Job Duties:**

* 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.

**Job Requirements:**


* 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.

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll 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 careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


Posted: 2019-07-01 Expires: 2019-08-31

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Regulatory Compliant Analyst

Kelly Services
San Jose, CA 95115

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