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28 days old

Manager Regulatory Affairs

Kelly Services
Santa Ana, CA 92702
+ Job title: Manager, Regulatory Affairs

+ Location: Santa Ana, CA

+ Schedule: Hybrid - 3 days on 2 days off

+ Salary: Commensurate with experience


**BASIC FUNCTION**


Assist and coordinate the compiling, preparation and assembly of regulatory submission and support files for medical devices and in vitro diagnostics registration worldwide. Such activities include: Technical File creation and preparation, Risk Management, FMEA, Essential Requirements, GSPR, outside references and various regulatory external and internal support as required.


**SCOPE**


Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDAs GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR, Australian Medical Device regulations and regulatory requirements for product registrations where products are distributed worldwide.


**ESSENTIAL DUTIES AND RESPONSIBILITIES**


+ Ensuring compliance of all processes and procedures to applicable standards.

+ Communicating with regulatory agencies, notified bodies, and competent authorities.

+ Prepare and maintain product registrations that include, but are not limited, to the following:

+ Substantial changes and new product submissions

+ Renewal of Technical Files and communication with corresponding Agents (EU AR, China, etc.)

+ US FDA 510(k) Premarket Notifications

+ US FDA Drug Master Files and annual updates

+ Technical Files for EU and EU AR

+ Oversee, manage and assist with the following activities:

+ Internal/External and Customer Audits

+ Change assessment to product design, specifications, or product manufacturing processes

+ New Product Committee (NPC) Design Control

+ Product Recalls

+ Field safety corrections

+ Mandatory Device Reporting (MDR), Mandatory Problem Reporting (MPR), Vigilance Reporting (EU), Adverse Events Reporting (Worldwide)

+ Writing and/or revising regulatory related standard operating procedures

+ Preparing monthly reports on product registration status

+ Provide regulatory approval for the following, but not limited to:

+ Non-conformances / CAPA's

+ Quality Planning

+ Risk Assessments

+ Document Changes (SOPs, labeling, etc.)

+ Assist in the assessment of Technical Department (R&D) activities that include, but are not limited to, the following:

+ MDR, MPR and/or vigilance investigations for complaints

+ Risk Management File Review and revision based upon complaint

+ Maintain all applicable licensing including: Local, State and National Regulatory licensing and registration renewals

+ Import/Export Permits


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-07-18 Expires: 2022-08-18

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Manager Regulatory Affairs

Kelly Services
Santa Ana, CA 92702

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