Regulatory Affairs Director: Expert Leader for Global Compliance

6 days ago


Warren, Maine, United States Joulé Full time

About the Role

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This is a highly respected position that demands expertise in regulatory affairs, strategic leadership, and compliance. The Manager, Regulatory Affairs will lead a high-performing team to ensure global regulatory compliance, drive strategic initiatives, and foster innovation throughout the product lifecycle.

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Key Responsibilities

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• Provide visionary leadership, coaching, and mentorship to Regulatory Affairs Associates to achieve project objectives and resolve complex challenges.">

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• Actively engage in day-to-day operations to address regulatory issues and ensure timely delivery of regulatory outcomes.">

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• Manage and prioritize tasks across multiple projects, ensuring alignment with organizational goals and strategic objectives.">

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Strategic Regulatory Guidance

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• Develop and implement regulatory strategies for new technologies and product modifications, considering domestic and international requirements.">

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• Prepare and review regulatory submissions to secure approvals from authorities like the FDA or Notified Bodies.">

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• Represent the Regulatory Affairs function on cross-functional teams, providing expert input on specifications, testing plans, and lifecycle strategies.">

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Qualifications

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• Minimum 8 years of experience in Regulatory Affairs, including 1 year of direct or indirect management experience.">

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• Proven success in securing FDA or Notified Body approvals for medical devices, drugs, or biologics.">

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• Strong skills in negotiation, listening, persuasion, collaboration, and analytical decision-making.">

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What We Offer

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Joulé provides competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life, and recognition programs that support unlocking potential and personal growth. Our expansive list of benefits includes group medical, dental, and vision plans, a robust wellness program, life insurance, disability coverages, and various voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance, and more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and provide vacation and sick time programs for associates. At Joulé, it's about protecting personal welfare, achieving personal goals, and offering extra touches for convenience, security, and peace of mind.



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