Kelly Science & Clinical is currently seeking a Remote Regulatory Specialist / International Registrations Writer for a long-term engagement with one of our Global Med Device clients out of California
***This role is remote role***
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. 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.
Regulatory Specialist – International Registrations is responsible for generating and providing technical documentation to maintain global product registrations for EMEA, LA, Japan, and APAC for a large-scale lifecycle management project.
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 Latin America, Asia Pacific, Japan and Europe, Middle East and Africa for product registrations.
Work with regulatory partners to ensure execution and approval of product registrations in accordance with project plans.
Researches, collects data, and addresses requests from local regulatory teams or regulatory agencies to prepare documentation required for health authority submissions
Work under minimal supervision, with benefit of previous regulatory experience.
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
Minimum education required:
A Bachelor's degree is required, preferably in a science or technical discipline.
A minimum of 2 years of related Regulatory experience is required.
Direct experience with international medical device registration is required.
Excellent technical writing skills required.
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.
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.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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