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Kelly Global Talent Solution

Regulatory Affairs

Post Date:Apr 15, 2019Type:Full-Time
Start Date:4/15/2019Salary:
Location:US-FL-Jacksonville Job Reference:US41JYAC_BH1568605
Skills:
 

Job Description:

Kelly Services has provided outstanding employment opportunities to the most talented individuals in the marketplace. Today, we are proud to offer a contract opportunity for a Regulatory Affairs Specialist with our client, a leader in the Pharmaceutical/Medical Device industry, Jacksonville, FL. Please send your resume to Alicia Cali at [Click Here to Email Your Resumé] or call at 216.256.7768.
Regulatory Affairs Specialist
Entry to mid-level professional position in Regulatory Affairs to support implementation and compliance with the EU Medical Device Regulations.  Primary responsibilities include support and assistance in preparation, submission, and maintenance of global regulatory documents/dossiers under direct supervision.
 
Adheres to environmental policy, procedures, and supports department environmental objectives.
 
ESSENTIAL FUNCTIONS / RESPONSIBILITIES




  • Prepares, compiles and submits global regulatory dossiers, US and International for new and existing products.

  • Complete Regulatory Impact assessments for product, process and package changes and communicate results to the appropriate departments. 

  • Coordinate and assist in the maintenance of licenses and authorizations for existing products (e.g., US PMA, International Registrations and Dossiers, updates to technical files), engineering and device changes requests. 

  • Participates in cross-functional project teams

  • Coordinates and assists in the review and approval of new and/or revised product labeling to ensure regulatory compliance.

  • Provides Regulatory Affairs support during internal and external audits (as needed).

  • Update Regulatory Affairs procedures as needed to comply with EU MDR Requirements.



 
Minimum education required for competent performance:




  • BS degree (scientific discipline preferred) or equivalent

  • Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance: years of experience with a BS degree (scientific discipline preferred) or equivalent.



Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States.
Why Kelly?




  • As a Kelly Services employee, you will have access to numerous perks, including:

  • Exposure to a variety of career opportunities as a result of our expansive network of client companies 

  • Career guides, information and tools to help you successfully position yourself throughout every stage of your career

  • Access to more than 3,000 online training courses through our Kelly Learning Center

  • Weekly pay and service bonus plans

  • Group-rate insurance options available immediately upon hire*



 
Apply Today!
 
*Available for purchase and administered by a designated third-party vendor
 
                                                                                                                               
                                                                                                                                                                                                                                                                                                                                                               
                                                                               





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.



About Kelly 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 kellyservices.com 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.





Contact Information
Kelly Global Talent Solution
Name: Alicia Cali


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