Job Description

Job Title: Manager, Regulatory Affairs

Location: Lakewood, CO - Hybrid

Salary: $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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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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