Job Description

GA Rogers & Associates has partnered with a global medical device organization who is eager to identify a Regulatory Affairs & Quality Assurance leader to join their growing team here in North Texas.

This role is a hybrid work arrangement located off the Dallas North Tollway, just north of George Bush.

In this position, you'll be instrumental in guiding the regulatory and quality strategies for the growing organization.

Direct Hire - $90,000-$140,000 + bonus potential

The details:

• Orchestrating Regulatory & Quality Strategy : Charting the course for the organization's regulatory and quality endeavors, ensuring seamless compliance and market access.
• Igniting a Culture of Quality : Be the driving force behind a robust quality culture across North American operations and beyond, fostering a mindset of continuous improvement that elevates standards.
• Becoming a Regulatory Authority : Leverage your deep understanding of medical device regulations (Class I/IIa) and the international landscape to guarantee products not only meet but exceed the highest global benchmarks.
• Leading with Vision & Collaboration : Mentor and empower teams, forge strong partnerships with cross-functional departments, and contribute to the development of impactful global regulatory and quality frameworks.
• Fueling Innovation & Growth : Play a key role in the organization's exciting evolution into a world-class medical device powerhouse by implementing streamlined, effective systems and processes.

Your expertise will be critical in:

• Providing strategic regulatory and quality guidance, proactively navigating the ever-evolving regulatory environment.
• Spearheading vital quality initiatives, including meticulous document control, proactive post-market surveillance, and effective non-conformance management, all with a continuous improvement lens.
• Empowering colleagues through engaging and informative training sessions on crucial Regulatory and Quality topics.
• Ensuring the accuracy and regulatory adherence of all product packaging, labeling, and promotional materials.
• Taking ownership of and effectively resolving quality issues to maintain product integrity and patient safety.
• Leading internal audits and supporting supplier/licensee audits to uphold the highest quality standards throughout the supply chain.
• Playing a central role in securing and maintaining essential regulatory registrations and certifications.
• Contributing your insights to global regulatory and quality projects, helping to define worldwide best practices.
• Collaborating with the Compliance Officer to ensure unwavering adherence to all state and federal regulations.
• Contributing to the preparation and submission of critical reports to the FDA, including Medical Device Reports (MDRs).

What makes you the ideal candidate?

• You possess a Bachelor's, Master's, or Doctoral degree in a life science or a related discipline
• You bring a minimum of 4 years of hands-on experience successfully navigating the complexities of medical device regulations.
• Your leadership abilities are evident through at least 2 years of experience in management or supervisory roles.
• You are a strategic thinker with exceptional analytical and problem-solving skills, adept at tackling complex challenges with clarity and precision.
• Bonus points for ISO 13485 audit experience!

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