Director of Regulatory Affairs

Overview:

This role will serve as the FDA regulatory subject matter expert for our medical device 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 aligned with FDA requirements.

  • Provide expertise and guidance in interpreting FDA 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 interfacing with the FDA in the medical device or medical diagnostics industry. OTHERS NEED NOT APPLY.

  • 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.

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