Regulatory Affairs Director, Strategic Compliance

5 days ago


Warren, Maine, United States Joulé Full time

We are seeking a seasoned Regulatory Affairs Director to lead our Strategic Compliance team in ensuring seamless domestic and international regulatory operations. As a key member of the leadership team, you will drive strategic regulatory initiatives and foster innovation while maintaining compliance throughout the product lifecycle.

Responsibilities:

  • 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.
  • 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.
  • Maintain and expand knowledge of global regulatory frameworks, ensuring the team applies best practices and remains compliant with evolving standards.
  • 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.

About the Role:

As a Regulatory Affairs Director at Joulé, you will be responsible for driving strategic regulatory initiatives and ensuring compliance with domestic and international regulations. With a strong background in regulatory leadership and extensive experience in obtaining FDA or Notified Body approvals, you will serve as a key collaborator across teams, providing regulatory expertise and fostering innovation throughout the product lifecycle.

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.

What We Offer:

At Joulé, we offer competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.

Estimated Salary: $125,900 - $157,400 + 15% bonus, based on location in Lakewood, CO and industry standards.



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