Lindsey Regulatory Affairs Consulting, LLC

#RAPSConvergence2024 will forever be a highlight in my career. Having the opportunity to speak to students, being honored as a #RAPSFellow, and networking with industry experts such as Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices and Dr. Jethro Ekuta has truly shaped me in more ways than one. Beginning my career in manufacturing at Cook Medical to creating Lindsey Regulatory Affairs Consulting, LLC my journey has been so rewarding and challenging. I’m passionate about patient safety, representation of POC, and educating future regulatory experts. #IAMREGULATORY I absolutely love adding ribbons to my badge each year and we need a faculty badge ??. Next ribbons will be Author, Committee Member, and Board Member one day. ?? See you next year Regulatory Affairs Professionals Society (RAPS) in Pittsburgh! #RAPS #RegulatoryAffairs

2nd speaking opportunity in the books. Thankful to Kim A. Young for reaching out to me and Regulatory Affairs Professionals Society (RAPS) for creating opportunities like this to reach the next generation of regulatory professionals. #RAPSConvergence2024

Join us!

I am excited to announce that I have been accepted into the Milestone Circles program at the Nasdaq Entrepreneurial Center! Milestone Circles is a 12-week program that provides women entrepreneurs with the access, resources, and knowledge they need to grow. Over the next 12 months, Milestone Circles will support thousands of women and their businesses! This program remains free for entrepreneurs thanks to the generous support of the Wells Fargo Foundation. To apply or learn more, visit?https://lnkd.in/g-nycF-h #MilestoneCircles #WomenEntrepreneurs #Accelerator

?? Regulation (EU) 2024/1860?it is!!! ?? The long-awaited regulation amending #MDR and #IVDR. ??? Key changes: ?? gradual roll-out of EUDAMED ?? obligations to inform in case of interruption or discontinuation of supply ?? transitional provisions for certain in vitro diagnostic medical?devices https://lnkd.in/eVF3EU2C #tuvsud #notifiedbody

We are pleased to announce organizational changes within the Center for Devices and Radiological Health (CDRH) to help strengthen and better position the Center to meet our mission to protect and promote the public health.? · CDRH is elevating the Office of Communication and Education (OCE) into a Super Office. OCE’s name has changed to the Office of Communication, Information Disclosure, Training and Education (OCITE) to better represent the broad spectrum of their expertise. · Structural changes have occurred within the Office of Product Evaluation and Quality (OPEQ) in both the Office of Clinical Evidence and Analysis (OCEA) and the Office of Health Technology 4 (OHT4): Surgical and Infection Control Devices to help improve efficiencies within the offices and better meet the needs of our customers. https://lnkd.in/enbrFXTE

The FDA released a summary report from the Public Workshop to Enhance Clinical Study Diversity held in collaboration with Clinical Trials Transformation Initiative (CTTI), which discussed strategies to increase broader representation in clinical trials. View report ???https://lnkd.in/eUuNeBUn FDA has a longstanding commitment to promote the inclusion of underrepresented populations in clinical trials and to help reduce barriers that may prevent the enrollment and retention of a diverse trial population.

Thank you to Canvas Rebel for the feature! https://lnkd.in/g2zNwyJp