System One
Manager, Regulatory Affairs
System One, Denver, Colorado, United States, 80285
Job Title:
Manager, Regulatory AffairsLocation:
Lakewood, CO - HybridSalary:
$125,900 - $157,400 + 15% bonus
Job Summary:The Manager, Regulatory Affairs will lead and guide a high-performing Regulatory Affairs team, ensuring compliance with domestic and international regulations while driving strategic regulatory initiatives. This position requires a seasoned professional with extensive experience in obtaining FDA or Notified Body approvals and a strong background in regulatory leadership. You will serve as a key collaborator across teams, providing regulatory expertise and fostering innovation and compliance throughout the product lifecycle.
Key Responsibilities:
Leadership and Team Development:
Provide leadership, coaching, and mentorship to Regulatory Affairs Associates to achieve project objectives and resolve technical or operational challenges.
Actively engage in day-to-day operations to address complex issues and ensure timely delivery of regulatory outcomes.
Manage and prioritize tasks across multiple projects, ensuring alignment with organizational goals.
Strategic Regulatory Guidance:
Develop and implement regulatory strategies for new technologies and product modifications, considering domestic and international requirements.
Prepare and review regulatory submissions to secure approvals from authorities like the FDA or Notified Bodies.
Represent the Regulatory Affairs function on cross-functional teams, providing expert input on specifications, testing plans, and lifecycle strategies.
Regulatory Knowledge and Compliance:
Maintain and expand knowledge of global regulatory frameworks, ensuring the team applies best practices and remains compliant with evolving standards.
Review and provide input on advertising and promotional materials to ensure compliance with global regulations.
Interpret regulations and policies, providing clear guidance to internal teams and senior management.
Stakeholder Engagement:
Act as the primary regulatory contact for specific business areas or geographies, fostering proactive collaboration with internal and external stakeholders.
Negotiate with regulatory authorities to expedite the development, review, and approval process for submissions.
Effectively communicate regulatory strategies and project updates to senior leadership and relevant teams.
Process Improvement:
Identify opportunities for new or updated regulatory procedures and lead their development and implementation.
Continuously refine internal processes to enhance efficiency and compliance.
Qualifications:
Minimum of 8 years of experience in Regulatory Affairs, including 1 year of direct or indirect management experience.
Proven success in securing FDA or Notified Body approvals for medical devices, drugs, or biologics.
Strong skills in negotiation, listening, persuasion, collaboration, and analytical decision-making.
Ability to manage complex projects and drive regulatory strategy while balancing compliance and business objectives.
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Manager, Regulatory AffairsLocation:
Lakewood, CO - HybridSalary:
$125,900 - $157,400 + 15% bonus
Job Summary:The Manager, Regulatory Affairs will lead and guide a high-performing Regulatory Affairs team, ensuring compliance with domestic and international regulations while driving strategic regulatory initiatives. This position requires a seasoned professional with extensive experience in obtaining FDA or Notified Body approvals and a strong background in regulatory leadership. You will serve as a key collaborator across teams, providing regulatory expertise and fostering innovation and compliance throughout the product lifecycle.
Key Responsibilities:
Leadership and Team Development:
Provide leadership, coaching, and mentorship to Regulatory Affairs Associates to achieve project objectives and resolve technical or operational challenges.
Actively engage in day-to-day operations to address complex issues and ensure timely delivery of regulatory outcomes.
Manage and prioritize tasks across multiple projects, ensuring alignment with organizational goals.
Strategic Regulatory Guidance:
Develop and implement regulatory strategies for new technologies and product modifications, considering domestic and international requirements.
Prepare and review regulatory submissions to secure approvals from authorities like the FDA or Notified Bodies.
Represent the Regulatory Affairs function on cross-functional teams, providing expert input on specifications, testing plans, and lifecycle strategies.
Regulatory Knowledge and Compliance:
Maintain and expand knowledge of global regulatory frameworks, ensuring the team applies best practices and remains compliant with evolving standards.
Review and provide input on advertising and promotional materials to ensure compliance with global regulations.
Interpret regulations and policies, providing clear guidance to internal teams and senior management.
Stakeholder Engagement:
Act as the primary regulatory contact for specific business areas or geographies, fostering proactive collaboration with internal and external stakeholders.
Negotiate with regulatory authorities to expedite the development, review, and approval process for submissions.
Effectively communicate regulatory strategies and project updates to senior leadership and relevant teams.
Process Improvement:
Identify opportunities for new or updated regulatory procedures and lead their development and implementation.
Continuously refine internal processes to enhance efficiency and compliance.
Qualifications:
Minimum of 8 years of experience in Regulatory Affairs, including 1 year of direct or indirect management experience.
Proven success in securing FDA or Notified Body approvals for medical devices, drugs, or biologics.
Strong skills in negotiation, listening, persuasion, collaboration, and analytical decision-making.
Ability to manage complex projects and drive regulatory strategy while balancing compliance and business objectives.
#J-18808-Ljbffr