Director of Regulatory Affairs

Overview:

This role will serve as the regulatory subject matter expert for our business by taking a hands-on role in defining, deploying, and leading regulatory and compliance strategies.

Essential Responsibilities:

  • Craft, implement and maintain a Company-wide medical device regulatory affairs system.
  • Provide expertise and guidance in interpreting regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained and results are achieved.
  • Develop regulatory strategies for operational improvements and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory agencies.
  • Oversee the development and implementation of company and departmental SOP’s.
  • Ensure compliance with applicable FDA, GMP, ISO, protocols and regulations.
  • Evaluates manufacturing changes for regulatory impact and to ensure compliance.
  • Define ownership, roles, and responsibilities for specific individuals and teams.
  • Prioritize resources for initiatives as directed by regulatory affairs with appropriate management of compliance needs, timing and budget.
  • Develop and maintain compliance training programs.
  • Establish metrics for evaluating the quality and timelines of submissions.
  • Ensure department compliance with company policies and procedures.
  • Manage the preparation of registration packages.
  • Manage submission data requirements and deliverable dates with regulatory bodies.
  • Partner with Quality as key contacts for regulatory body interactions including preparation of submissions and strategy for meetings, inspections, and agency responses.
  • Maintain awareness of regulatory legislation and assess its business impact.
  • Oversee review and revision of Regulatory Affairs documents.
  • Provide direction and successful attainment of CE Mark.

Education/Experience:

  • A minimum of 8 years regulatory affairs experience in the medical device, pharmaceutical, and/or medical diagnostics industry.
  • Be a results-oriented leader with excellent collaboration and project management skills.
  • Possess solid decision-making capabilities with strong expertise of regulatory compliance requirements.
  • CE Mark experience is highly desirable.

 

 

Register for updates

Receive the latest updates from Breathe Technologies