Strategically Strong, yet Tactically Sharp

President & CEO

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Stephanie Rallis-Daw is the President and CEO at Rallis-Daw Consulting LLC. Stephanie has almost two (2) decades of experience in the highly regulated life science industry. She holds a Bachelor of Science in Biology emphasis Pre-Medicine from The Master's University (Santa Clarita, CA), currently works for a Notified Body as a lead auditor and technical documentation reviewer and holds the following industry recognized certifications:

 

• Exemplar Global Certified Medical Device Lead Auditor (EU 2017/745, European Union Medical Device Regulation (EU MDR), ISO 13485:2016 and Regulatory Compliance Audit)

• American Society of Quality (ASQ) Certified Quality Engineer (CQE)

• ASQ Certified Medical Device Auditor (CMDA)

• MDSAP Training as part of employment with Notified Body (25+ hours completed in July 2023)

• ISO 14971:2019 Training as part of employment with Notified Body (8 hours completed in July 2023)

• Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Certification (RAC) Devices

• Zschool Mentor Pro Certification

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In her free time she enjoys walks on the beach and family time.

Office Management

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Dana Pembroke is the Office Manager at Rallis-Daw Consulting. Dana has over 15 years of experience in marketing and office management. She holds a Bachelor of Fine Arts in Human Development from California State University, Long Beach. Dana, a native to Southern California, is married and has two children. In her free time she enjoys traveling, photography, hot yoga and cooking.

Quality System Manager

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Sonia C. Loya is the Quality System Manager at Rallis-Daw Consulting, LLC. and is a certified Quality Improvements Associate. Sonia has over 15 years of progressive experience in Quality Systems, process improvement, quality compliance, and product development initiatives. Sonia is a contributor at the Rallis-Daw Consulting, LLC. where she will support eQMS integration and implementation with the intention of empowering customers to achieve governance and compliance. Sonia is a lifelong resident of San Juan Capistrano, California, where she resides with her husband and five children. During her free time, she enjoys cheering on her children as they compete in sports and or enjoys reading a romantic novel.

Senior Manager of PMO

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Sartaj Kaur-Hurrle, often known as Taj, boasts an impressive track record of almost a decade in the realms of medical device quality assurance and regulatory affairs. She launched her career in a startup that created products for women where she learned about all aspects of Regulatory and Quality. She's well-versed in working with the FDA and various global regulations, like Europe's Medical Device Regulation (MDR), Australia's Therapeutic Goods Administration (TGA), Health Canada, and others.

 

A few interesting tidbits about Taj:

 

• She's a lefty.

• She learned to speak English when she was 14.

• Taj resides in San Diego with her husband and twin daughters