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21 days old

Regulatory Affairs Specialist

Kelly Services
Santa Ana, CA 92702
Kelly Science & Clinical is currently seeking a **Regulatory Affairs Specialist** for a long-term engagement with one of our Global Med Device clients out of Santa Ana, CA


*****This role is NOT remote*****


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, Vision, 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.


**Job Goal:**

Southern California based Regulatory Specialist II Regulatory Operations is responsible for generating and providing documentation to maintain global product registrations for US, Canada, EMEA, LA, Japan and APAC for large-scale lifecycle management projects and perform various regulatory operational tasks.


**Responsibilities:**

Coordinate, compile, author, format and supply the required documentation (including the management of obtaining non-technical documents such as Certificates to Foreign Government, legalized/apostilled documents, etc.) to regulatory teams in Asia Pacific

Researches, collects data, and addresses requests from local regulatory teams or regulatory agencies to prepare documentation required for health authority submissions

Coordinate and evaluate impact of new regulations

Conduct change evaluations

Compile management report and maintain global regulatory data

Maintain site license and device listing documentation

Monitor and track invoices from external partners

Work under minimal supervision

Requires a general use and application of Regulatory concepts, practices, and techniques.

Develop solutions to a variety of problems of moderate scope and complexity.

Perform other duties as assigned by the manager of this position


**Qualifications** :

A Bachelors degree is required, preferably in a science or technical discipline.

A minimum of 2 years in Regulatory Affairs.

Strong organizational skills, accuracy, and attention to detail

Strong project management skills

A team player who is able to work in a fast-paced environment.

Analytical thinking, problem solving, and investigative skills are required.

Experience in the application of Quality Management System Standard ISO 13485.

Demonstrable track record of successfully managing multiple projects simultaneously is required.

Excellent English written and oral communication skills are required.

Proficiency in Microsoft Office and all related applications is required.


**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: 2021-08-27 Expires: 2021-10-04

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Regulatory Affairs Specialist

Kelly Services
Santa Ana, CA 92702

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