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Regulatory Affairs Specialist in Mansfield, MA at APEX Systems

Date Posted: 1/9/2019

Job Snapshot

Job Description

Job #:  926982

Immediate Opening for Regulatory Affairs Specialist in South Shore, MA
The Regulatory Affairs Specialist is responsible for coordinating activities to support of international product registrations, database management, export certificates and technical documentation. 
Specific activities include but are not limited to:
•Maintain up-to-date knowledge of global regulations 
•Support Cardinal worldwide product registrations
•Maintain country specific site registration requirements 
•Maintain current regulatory databases to ensure accurate regulatory data 
ESSENTIAL FUNCTIONS:
•Collaborate with Cardinal regional regulatory teams to obtain required registration documents upon fully understanding the local regulations
•Under direction, prepare international submissions and maintain existing regulatory approvals through letter to file, renewals etc. 
•Obtain regulatory information from various sources to maintain product information databases
•Organizes regulatory information resources and tracks and controls submissions.
•Organize and maintain regulatory product files
•Obtaining/Maintaining Certificates of Foreign Government (CFG)/Certificates of Free Sale (CFS)
•Other duties as assigned
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
•Effective problem-solving skills 
•Ability to create cross-functional partnerships
•Ability to work collaboratively in a team environment 
•Effective oral and written communication skills 
•Effective problem-solving skills
MINIMUM REQUIREMENTS:
Education: 
•Bachelor Degree in scientific discipline, or significant experience in Medical Device Industry with a concentration in Regulatory Affairs
Experience: 
•1-3 years Regulatory Affairs experience or equivalent required
If interested please email resumes to tmcgrath@apexsystems.com with the subject line ' Regulatory Affairs'

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178