Regulatory Specialist
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Regulatory Specialist
Ref No.: 18-32499
Location: West chester, Pennsylvania
Position Type:Direct Placement
Experience Level: 8 Years
Start Date: 05/10/2018
 
  1. Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility.
  2. Identify regulatory trends and their implications; Develop & implement effective regulatory strategies to meet business objectives
  3. Analyze & communicate proposed, new or changing requirements, & devise strategies for their implementation, ensuring business goals are met.
  4. Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility.
  5. Educate, train, & advise company professionals to ensure compliance with RA requirements.
  6. Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety.
  7. Collect, summarize & evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight.
  8. Support continuous improvement activities with regard to areas of responsibility.
  9. Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility.