26 days old

The Regulatory Affairs Specialist II

Kelly Services
Santa Ana, CA 92702
**Title: The Regulatory Affairs Specialist II**

**Location: Santa Ana, CA**

**Pay: Competitive**

**Day Shift: Monday-Friday**


**Kelly Science & Clinical is excited to share this Opportunity with you.**

**THE COMPANY is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines.**

**THE COMPANY adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The companys consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support.**

**For over 50 years, THE COMPANY has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.**

**We are hiring a Financial Analyst. The Regulatory Affairs Specialist II will assist and coordinate the compiling, preparation and assembly of regulatory submissions and support files for medical devices and in vitro diagnostics registration worldwide in accordance with GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVDD 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/ GSPR, outside reference standards and various regulatory external and internal support as required.**


**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 ensuring that regulations related to in-country registration are 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**

**Experience/ Education:**

+ **B.S. or B.A. preferred**

+ **Two to three years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry**

+ **GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, MDR 2017/745, 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.**

**Ability to write, edit, speak and read English well**

**THE COMPANY is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.**

**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. (
Posted: 2022-07-22 Expires: 2022-08-22

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The Regulatory Affairs Specialist II

Kelly Services
Santa Ana, CA 92702

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