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Job Details

Regulatory Affairs Specialist

Savannah, GA

Date Last Verified
Jul 13,2018

Posted on
Jul 12,2018

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Salary: $80,000 DOEA leading healthcare professional is looking to hire an experienced Regulatory Affairs Specialist in their corporate headquarters located in Savannah, Georgia. This individual would be working with support of the Manager of QA/RA. Investigating and completing regulatory affairs activities would include assisting in the development of procedures along with coordinating with multiple departments to ensure requirements are properly met. Salary for this position is $80,000 depending on experience.KEY RESPONSIBILITIES: Prepare and submit registration documents Ensure requirements are effectively presented and followed for the registration of worldwide products Manage multiple regulatory affairs projects related to meeting requirements Represent regulatory affairs in cross-functional project teams, plan and schedule for regulatory deliverables, and participate in projects through completion as needed. Use influence and persuasion as needed to gain answers on projects and provide regulatory affairs deliverables on schedule Identify the least burdensome approach to promote speed to market and compliance with applicable regulations Combine knowledge of scientific, regulatory and business issues to meet required legislations Identify issues and analyze broad scope implications of changing regulations and guidance Utilize technical regulatory skills to propose strategies on complex issues Interface with a variety of management levels on regulatory affairs matters, often requiring the coordination of activity across functional groups Other activities as assigned by the Manager of QA/RA WORK EXPERIENCE: Recent experience in medical device industry is preferred. Familiarity with FDA medical device regulations is essential. Familiarity with ISO 13485, CMDR and EUMDD requirements is strongly preferred. PREFERRED EDUCATION: Bachelor's degree (B.S.) from four-year College or University preferred. KNOWLEDGE, SKILLS & COMPETENCIES: Ability to read and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to create reports, business correspondence, and procedure manuals Ability to effectively present information and respond to questions verbally, in writing, and in group presentations Must be skilled in Microsoft Word, Excel, Outlook and Power Point DOT Hazardous Materials I Dangerous Goods Certification preferred TRAVEL / PHYSICAL DEMANDS:Travel typically less than 10%. Office environment. No special physical demands required. Job demands may require long periods of sitting, standing, telephone work, and computer work Job demands may require occasional heavy lifting, up to 15 pounds. Profile Correlation: Professional 5Benefits of working with Express:Excellent pay Holiday and Vacation Pay Medical Benefits 401K Training Scholarship Opportunities National Retailer Discounts Referral Bonuses Need more information about this job?Complete an application at ****or ****. If available, please include your resume by email to ****. Please add the u201cAccountantu201d to the subject line of your email. Apply Now!Looking to take your first step toward a new career success today! Apply with Express Employment Professionals ****or stop by our office between 9 - 11AM, Monday thru Friday at 2 Park of Commerce Blvd., Suite I, Savannah GA 31405. We are located facing Chatham Parkway close to the intersection with Interstate 16.Express Employment Professionals works with job seekers to help them find the right job for their skills and experience. We have a variety of jobs available, which are full-time, part-time, and temporary positions. As one of the leading staffing companies in North America, Georgia, and the greater Savannah area, we are ready to help you take the next step in your career.Express Employment Professionals of Savannah has helped applicants build their career since 2005. In 2017, our team put more than 1,300 associates to work in the greater Savannah area. Globally, Express employs more than 500,000 people across more than 800 franchise locations worldwide.Take the first step toward new career success, apply with Express Employment Professionals today.Express Office: Savannah2 Park of Commerce BoulevardSuite ISavannah, GA 31405,employmentType:[,OTHER],title:Regulatory Affairs Specialist,url:****States,postalCode:}},hiringOrganization:{@type:Organization,name:Express Employment - CO | FL | GA | HI,logo:****{@context:****Affairs Specialist}}]}

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