1+ months

Regulatory Specialist - Quality Systems / Regulatory Affairs, Irvine, CA

Kelly Services
Santa Ana, CA 92702
**Regulatory Specialist - Quality Systems / Regulatory Affairs, Irvine, CA**

**Position Type:** 3-6 month temporary with potential to extend

**Position Overview:** Assist and coordinate the compiling, preparation and assembly of regulatory submission and support files for medical devices and in vitro diagnostics registration worldwide in accordance with GMP, ISO 13485, MDD 93/42/EEC, IVD D 98/79/EC, ISO 14971, Canadian Medical Device Regulation, and related country regulations for medical devices and in vitro diagnostics. Such and activities include: Technical Files, Risk Management, FMEA, Essential Requirements, outside references and various regulatory external and internal support as required.

**Essential Duties and Responsibilities:**

+ 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

+ Assist in the renewal and maintenance of, but not limited to, the following:

+ Local, State and National Regulatory licensing and registration renewals

+ Import/Export Permits

+ Assist in the identification of, but not limited to, the following:

+ Relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to registration requirements

+ Notification to management of new and revised documents referenced above

+ Assist in the preparation and maintenance of product registrations that include, but are not limited, to the following:

+ 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

+ Registration Documents for China and ROW

+ Understanding, implementation of all the regulations assigned in each country in which products are registered and distributed.

+ Assisting in insuring that regulations related to in-country registration is to clearly stated to ensure compliance with product registration for new or registered products.

+ Assisting in ensuring that distributors of IS products are observing the regulations as mandated by regulatory authorities in-country, including that of products that are registered

+ Assist with, but not limited to, the following:

+ 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

+ Assist in the approval of, but not limited to, the following:

+ Changes to procedures

+ Product promotional material

+ Product IFUs

+ Irvine Scientific Website

+ Primary back-up to the Senior Regulatory Affairs (RA) Manager

+ Other duties as assigned or required.

**Job Requirements:**

+ Bachelor's degree (BS)

+ Two (2) to three (3) years of direct Quality Assurance (QA) and Regulatory experience in the medical device and/or pharmaceutical industry.

+ Knowledge of the following: GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824).

+ Quality control methodology, QA controls systems and production methodologies.

+ Experience in cell, tissues culture and/or embryology. Experience can be from education or industry.

+ Ability to obtain cooperation from other groups and lead cross functional teams.

+ Experience with risk management and Failure Mode Effects Analysis (FMEA).

+ Understanding of validation of processes and equipment, methods validations, process investigations, technical evaluation.

+ Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat.

**Physical Demands:**

+ While performing the duties of this job, the employee is regularly required to sit, talk with customer and regulatory auditors and other business contacts on the telephone frequently; therefore, the ability to hear well is essential.

+ The employee frequently is required to read, compile, compute, and record numerical and statistical data.

**Work Environment:**

+ The noise level in the work environment is that of a busy operations office with telephones, computers and printers operating and with frequent people interruptions.

+ Some exposure to manufacturing and lab settings are inherent with position.

**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7563 or Email at or to schedule a time to connect directly:**

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

Kelly Science 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. 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


Posted: 2020-03-16 Expires: 2020-05-30

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Regulatory Specialist - Quality Systems / Regulatory Affairs, Irvine, CA

Kelly Services
Santa Ana, CA 92702

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