CenterWatch

1+ months

Complaints & Compliance Specialist

Kelly Services
South San Francisco, CA 94080
**Complaints & Compliance Specialist, South San Francisco, CA**



**Job Summary:** Under the direction of Technical Support Management, performs compliance activities including Complaint Handling, and Regulatory Reporting support for the company Quality System in compliance with FDA Code of Federal Regulations (21 CFR 820, 803, and 806), ISO 13485, applicable international regulations, and company Policies and Procedures.



**Essential Duties and Responsibilities:**




+ Serves as the lead to ensure accurate and timely regulatory reporting in accordance with applicable international regulatory requirements (e.g. ISO, Health Canada, ANVISA) and FDA Quality System Regulations.

+ Prepare, review, submit, and maintain Medical Device Reports (MDR) and Medical Device Vigilance (MDV) reports meeting country regulatory reporting and timeliness requirements.

+ Review and evaluate technical services inquiries and complaints to ensure compliance, accuracy, and completeness; immediately escalate product quality issues to management.

+ Manage and update Tickets associated with complaints.

+ Collaborate with Technical Support Specialists, Field Service Engineers, Clinical Support Specialist, or Subject Matter Experts to ensure complaint investigation documentation is completed in accordance to established regulations.

+ Record, document, and post meeting minutes for compliance team meetings, as applicable

+ Compile, prepare, review, and manage Quality System documentation (Complaint, eMDR, CAPA, SCAR, & Recall) in close collaboration with Technical Support Services and Quality Assurance & Regulatory Affairs management.

+ Support validation activities associated with software tools used for complaint handling and regulatory reporting in accordance with regulatory requirements.

+ Serves as Core Team Member to establish training program for Regulatory Reporting (MDR / MDV).

+ Ensures that regulatory reports and associated Quality System documentation is entered or referenced into the applicable quality record (e.g. complaint, correction & removal file).

+ Participates in external and internal regulatory audits as required for matters related to TSS, Complaints, Regulatory Reporting, and Corrections & Removals.



**Job Requirements:**




+ Bachelor Degree (BS) in a Biological science-related field, including Biomedical Engineering. Master's Degree (MS) preferred.

+ Requires in depth understanding of Complaints; MDR ; and Corrections & Removals (FDA 21 CFR 820, 803, and 806 & ISO 13485) is required with a minimum of 3 years' experience in complaints handling, regulatory reporting, and corrections & removals (recalls) as it applies to medical device industry (IVD experience a plus).

+ Strong investigational and problem solving skills. Root cause analysis techniques a plus!

+ The ability to communicate Quality System requirements and manage compliance of same is expected.

+ Must work across functional teams within the organization

+ Attention to detail and timeliness are critical and a must

+ Excellent communication (verbal and written) and interpersonal skills required

+ Basic statistical methods including trend analysis, pareto, and other basic charting techniques is a plus.



**Working Conditions:**



This position may require visits to customer sites which are medical facilities. These facilities may have certain requirements which company representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings.

Must agree to provide required immunization records and/or agree to acquire required immunizations in order to gain access to customer sites as required by customers. You may be required to register at vendor credentialing



**Physical and Environmental Demands:**



To perform this job successfully, the individual must be able to work on a computer for extended periods of time and perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and / or ability required to be successful. Additional duties may be assigned in the future as required. Reasonable accommodations may be made for those individuals with disabilities in order to perform the essential functions.






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding 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 90 of the Fortune 100 companies and found opportunities for more than 10,000 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.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-10-07 Expires: 2019-12-07

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Complaints & Compliance Specialist

Kelly Services
South San Francisco, CA 94080

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