Regulatory Affairs Manager

Jacksonville, FL 32256

Posted: 07/30/2019 Employment Type: Full Time Industry: Medical Equipment Pay Rate: 80000 Branch: Jacksonville, FL Division: Professional

At Work Personnel is currently seeking a Regulatory Affairs Project Manager to join our client’s team in Jacksonville, FL. Direct Hire opportunity, must be able to work W-2 directly for the end client. No C2C candidates will be considered.

Local candidates ONLY - client will not offer relocation assistance at this time.

Job Description:

Responsible for leading project submission for regulatory approvals acts to identify and resolve regulatory problems. Exercises discretion and independent judgment related, but not limited to, domestic and international regulatory submissions and interfacing with regulatory authorities on the submissions.

Requirements and Duties:

  • Bachelor’s Degree with six years of experience in regulatory affairs OR ten years experience in regulatory affairs or regulated industry
  • Possess intermediate to advanced level knowledge of Microsoft Office and ERP Systems
  • Researches regulatory issues and provides supervision, guidance, and advice to cross-functional team members
  • Reviews labeling/advertising for compliance and regulatory requirements for compliance with submissions
  • Review and identify domestic and/or international regulatory pathways for initial product designs and recommend changes or refinements based on initial regulatory outcomes
  • Researches requirements (domestic and international) and provides options for regulatory submissions, approval pathways, and compliance activities
  • Tracks the status of applications under regulatory review and provides updates to the company
  • Execute domestic and international regulatory submissions, license renewals, and registrations to regulatory agencies
  • Assess product change requests for impact on regulatory filings
  • Builds strategic partnerships to further departmental and organizational objectives
  • Provide monitoring of the regulatory environment (specific regulations, guidance, and other relevant information by product types, geography, etc.) applicable to company products
  • Maintains positive and cooperative communications and collaborations
  • Maintains high integrity and confidentiality of company and department information
  • Ability to work effectively with all levels of internal and external associates, customers, and colleagues
  • Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
  • Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem-solve
  • Ability to work with minimal supervision
  • Ability to manage multiple priorities
  • Ability to work both independently and within a team environment
  • Performs other related duties and responsibilities, on occasion, as assigned

If you are ready to take your career to the next level submit your resume today!

At Work Personnel is an Equal Opportunity Employer (EOE)

 

  • 4-year degree plus 6 years work experience in a regulated industry - 10 years of experience in regulated industry

Tim Simmons
Senior Recruiter

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