Global Regulatory Affairs Specialist III (ID#009)

Fort Lauderdale, Florida

Post Date: 07/14/2017 Job ID: JN -072017-9021
Global Regulatory Affairs Specialist III-Medical Device

A growing medical device manufacturing in Ft. Lauderdale, FL is looking for a Global Regulatory Affairs Specialist III. Great opportunity and growth potential! This is a permanent position and will provide relocation assistance as well.

SUMMARY
Assists with creating and compiling domestic and international product registrations requiring governmental approval, to include related activities such as review of technical documents and labeling, identifying and monitoring global registration requirements and conducting searches/updates of applicable guidelines and standards, familiar with Quality System concepts, practices and procedures, coordinates efforts with R&D, Supply Chain, Marketing and customer regulatory personnel.

ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Prepare and submit technical summaries and domestic and international product approval submission packages, applications, updates and renewals
  • Conduct searches/updates for domestic and international guidelines and standards and provides summaries, recommendations, and process improvements
  • Identify and monitor domestic and global/country regulatory and product reimbursement registration requirements
  • Generate/revise quality system procedures and product instructions for use/labeling per current regulatory requirements
  • Review technical documents and labeling in support of preparing regulatory product submissions
  • Require excellent technical writing skills and basic understanding of scientific concepts
  • Assist with Regulatory Complaint Reviews
QUALIFICATIONS
  • Bachelor of Science degree (B.S.) in a scientific discipline from four-year college or university, and 5+ years regulatory affairs experience within medical device, 510k submissions
  • International regulatory submissions experience, to include creating scientific summaries related to product approval submissions. Asian and Latin American markets highly preferred.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Mastery of the English language in written form is required. Ability to proofread documents. Ability to write reports, business correspondence, and procedure manuals.
BENEFITS:
  • Medical/Dental/Vision
  • Life insurance/disability programs
  • Matching 401(k) Plan
  • Generous Paid time off program
SRG Life Sciences offers the industry flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services in the clinical, manufacturing, medical and scientific fields. Through our innovative approach and proprietary database of over one million professionals, SRG Life Sciences offers ready access to the talents that drive today's rapid paced and competitive landscape. Additionally, SRG Life Sciences has a proven track record of placing cross-functional roles such as Information Technology, Accounting and Finance, Engineering, Professional and Government Services for our Life Sciences clients.
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