30 days old

Regulatory Affairs Writer

Kelly Services
Jacksonville, FL 32232
**Regulatory Affairs Writer**

The Regulatory Affairs Writer will:

+ 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.


+ A Bachelors Degree and a minimum of 2 years regulatory affairs work experience is required.

+ 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** **** **?**

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at
Posted: 2019-11-15 Expires: 2019-12-16

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Regulatory Affairs Writer

Kelly Services
Jacksonville, FL 32232

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