Regulatory Affairs Director

4 days ago


Morrisville, North Carolina, United States Planet Pharma Full time
Job Summary

Planet Pharma is seeking a highly experienced Regulatory Affairs professional to lead our regulatory strategies, submissions, and compliance initiatives. As a key member of our team, you will contribute to the company's growth and reputation within the medical device industry.

Key Responsibilities
  • Regulatory Strategy Development
    • Oversee the development and execution of regulatory strategies for new product development, including classification, pathway selection, and global market access.
  • Team Leadership
    • Provide leadership for the team, including performance management, talent development, succession planning, and employee development.
  • Collaboration and Partnership
    • Partner with cross-functional teams, including R&D, Clinical, Quality, and Design Assurance, to ensure alignment on regulatory strategy, submissions, and compliance activities.
  • Regulatory Document Preparation and Submission
    • Oversee the preparation, review, and submission of regulatory documents to regulatory authorities and international agencies, ensuring compliance with relevant regulations and guidelines.
  • Regulatory Agency Interaction
    • Manage negotiation and maintain interaction with regulatory authorities worldwide during the development and review process to ensure submission approval and clearances.
  • Risk Management and Compliance
    • Collaborate with cross-functional teams to assess and manage risks associated with products, processes, and regulatory changes. Implement risk mitigation strategies as needed.
  • Regulatory Audit and Inspection Support
    • Ensure preparedness and support of regulatory agency audits, inspections, and interactions, including facilitating document requests, coordinating responses, and addressing findings.
  • Regulatory Due Diligence and Integration
    • Provide regulatory due diligence and integration strategies for mergers, acquisitions, and partnerships to ensure smooth transitions and compliance, as needed.
  • Regulatory File Maintenance
    • Maintain organized and up-to-date regulatory files, records, and documentation, ensuring accessibility and accuracy for internal and external stakeholders.
Requirements
  • Education
    • Bachelor's degree in science, engineering, or a related field of study.
  • Experience
    • 7-10 years of related Medical Device Regulatory Affairs experience, with experience in Class I and II devices, and Class III experience preferred.
  • Leadership Experience
    • 5-7 years of leadership experience, including the proven ability to lead and motivate others.
  • Certifications
    • RAC certification is a plus.
What We Offer

Planet Pharma offers a competitive compensation package, commensurate with level of experience.



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