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30 days old

MDR Regulatory Affairs Writer - Remote

Kelly Services
Jacksonville, FL 32232 Work Remotely
**Kelly Science & Clinical is currently hiring a** **MDR (Medical Device Reporting) Regulatory Affairs Writer** **to support a long-term engagement at one of our Global Medical Device clients. This position is remote.**


**This role is a full-time, fully benefitted position. As a Kelly employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation and sick/personal time.**




**Responsibilities of the MDR Regulatory Affairs Writer includes:**



**Coordinate, compile, and supply regulatory documents to regulatory teams in Latin America, Asia Pacific and Europe, Middle East and Africa for new product registrations, new product introductions, renewals, change submissions, etc.**


**Work with regulatory partners to ensure rapid and timely approval of new products and renewals.**


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


**Monitors the external environment to help ensure compliance with new regulations, requirements, etc.**


**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.**






**Qualifications of the MDR Regulatory Affairs Writer includes:**



**Minimum of a Bachelors Degree**


**Minimum of 2 years of regulatory affairs work experience (beyond formal education) is required for competent performance**


**Knowledge of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is preferred.**


**Experience with Quality Management System Standard ISO 13485 is preferred.**


**Knowledge of International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is preferred.**


**Excellent written and oral communication skills are required.**


**Good analytical thinking, organization, problem solving and investigative 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. 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 https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-12-23 Expires: 2021-02-22

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MDR Regulatory Affairs Writer - Remote

Kelly Services
Jacksonville, FL 32232

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