Irvine, California

Kelly Science & Clinical is currently seeking a Regulatory Affairs Specialist II for a long-term engagement with one of our Global Med Device clients out of Irvine, CA

**Required to be on site Monday & Wednesday***

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Scope:
The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U.S. and international regulatory requirements. 
The Regulatory Affairs Specialist provides direct Worldwide Regulatory support to lifecycle management and new product development/new product introduction international product registrations.

Responsibilities: 
Coordinate, compile, and submit Regulatory documents to competent authorities, notified bodies, Regulatory Agencies, and international business partners.  Includes the preparation of key market international documents, including Technical Files. 
Work with Management to ensure rapid and timely approval of new products and continued Regulatory support of products marketed outside the United States. 
Create detailed international regulatory plans in concert with regional Regulatory contacts. 
Evaluate proposed product modifications for international Regulatory impact, completing Regulatory Assessments as needed.
Ensure compliance with applicable international regulations and standards
Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Assist with responses to health authority questions and other Regulatory correspondence.
Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
Update and maintain product eligibility to ensure right product/right country.
Requires use and application of Regulatory concepts, practices and techniques.
Provide solutions to extremely complex problems.
Provide regulatory guidance to project teams, as applicable.
Participate in the review and approval of international product labeling.
Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.

Qualifications
A Bachelor’s degree is required, preferably in a science or technical discipline.
A minimum of 4 years of related Regulatory experience is preferred.
Familiarity with Title 21 of the US Code of Federal Regulations Parts 800-1299 (21 CFR 800-1299) 
Experience in the application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is preferred.
Familiarity in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and CE marking is required; EU MDR familiarity is preferred.
Experience in the application of Quality Management System Standard ISO 13485.
Direct experience with international medical device registration is required.
Experience with change assessments for internationally marketed medical devices is preferred.
Previous experience working with globally dispersed affiliates and stakeholders is preferred.
Excellent English written and oral communication skills are required.
Good analytical thinking, problem solving, and investigative skills are required.
Proficiency in Microsoft Office and all related applications is required.
This position will be based in Irvine, CA



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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

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Irvine, California

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