Director Regulatory Affairs

137328
  • 210000 USD - 225000 USD
  • Montvale, United States
  • Permanent

Summary:
Independently lead regulatory strategy development, planning, and implementation for multiple complex products and programs and manage risk for the US. Act as primary liaison with FDA and all international Notified Bodies. This individual will be responsible for domestic and international filing activities and recall activities. Responsible for ensuring all regulatory compliance for all product lines manufactured and services in the US.

Responsibilities:
• Develops regional and multi-country regulatory strategy, and aligns regulatory strategies to regional strategies
• Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
• Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes
• Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
 

Qualifications:
• Bachelors degree in Life Sciences or Technical Field
• RAC Certification preferred
• Minimum of 10 years’ experience in Medical Device Regulatory Affairs
• In depth experience with FDA requirements, guidance documents, 510(k) submissions, Medical Device Directive, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• History of successful device submissions

Kasey Dillon Lead Recruiter

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