Orange County Regulatory Affairs Discussion Group

🌟 Event Recap: #OCRA Summer Social 🌟 Friday night’s #SummerSocial was a blast! 🎉 We gathered for an evening of fun, laughter, and networking under the warm summer sky. It was wonderful to see familiar faces and welcome new ones to #OCRA! From delicious food and refreshing drinks to engaging conversations and exciting raffles, the event had it all. Special thanks to everyone who made it possible and to all who attended – your energy and enthusiasm made the night unforgettable. Also, congratulations to the winners who won #Free registration to the #OCRAAnnualConference! Thanks to #OCRA Board and Social Committee volunteers Arta Zenunović, Shideh Sharifi, Anand Parikh, Ronald Kao! Congratulations to the #Winners of the raffle: Vicki Ong, Christopher Swanson, Martin Sprunck, Amoolya Girish, Erica Livingston, RAC, Kevin Yao and see you again at the #OCRAAnnualConference! Looking forward to more such events and continued connections - don't miss the #OCRAAnnualConference and register today: https://lnkd.in/gMEYefwY #SummerSocial #Networking #OCRAdg30 #OCRAAnnualConference #HappyHour #SummerSocial #RafflePrizes

If you have conducted or are planning to conduct #FDA-regulated clinical trials, you're likely familiar with the FDA's Bioresearch Monitoring (#BIMO) program. The program aims to protect the rights, safety, and welfare of clinical trial subjects through on-site inspections, data audits, and remote regulatory assessments to ensure the accuracy and reliability of study data, and ensure compliance with FDA regulations. Join us at the #OCRAAnnualConference (registration link: https://lnkd.in/gMEYefwY) and hear the latest updates in FDA #BIMO inspections from AUDREY VIGIL, Director, Investigations at FDA/ORA/OMPTO/OBIMO Division 2. This session will be moderated by Magda Michna, PhD, Chief Clinical, Regulatory, and Medical Affairs Officer at STAAR Surgical. #OCRA Diamond Sponsor: Allergan Aesthetics, an AbbVie company. #OCRAAnnualConference #OCRAdg30 #FDA #BIMO #ClinicalTrialDataIntegrity

🌞🍹 RSVP Now for #OCRA Summer Social Happy Hour!🍹🌞 Join Orange County Regulatory Affairs Discussion Group this Friday to unwind and connect at our #SummerSocial #HappyHour! Enjoy a relaxed evening with great company and refreshing appetizers and drinks! Plus, you'll have a chance to win exciting prizes in our raffle - including #Free registration to the #OCRAAnnualConference! 📅 Date: Friday, July 12 🕒 Time: 4pm-8pm PT (join anytime!) 📍 Location: Bosscat Kitchen & Libations (18169 Von Karman Ave, Irvine) ➡️ RSVP: https://lnkd.in/g-Jxy2XH #OCRA Diamond Sponsor: Allergan Aesthetics, an AbbVie company #SummerSocial #HappyHour #Networking #OCRA

Join #OCRAAnnualConference to learn about Regulation (EU) 2024/1860 that has been published today in the Official Journal of the European Union (#OJEU)! Our expert Notified Body speaker, Marta Carnielli from TÜV SÜD will give updates on this regulation, specifically in regards to the transitional provisions for certain #InVitroDiagnostic medical devices. ⏩ Register here: https://lnkd.in/gMEYefwY #InVitroDiagnosticMedicalDevices #EU #IVDR

This exclusive event kicks off the Orange County Regulatory Affairs Discussion Group's #OCRAAnnualConference and is open to the first 50 registrants. Secure your spot at the Welcome Reception by submitting the form by July 26, 2024: https://lnkd.in/d7ycVb-M 📅 Date: Thursday, August 1, 2024 🕔 Time: 5:30 PM 📍 Venue: The Hilton Waterfront Beach Resort, 21100 Pacific Coast Highway, Huntington Beach, CA 92648 USA If you have not registered for the #OCRAAnnualConference, don't miss it and register today here: https://lnkd.in/gMEYefwY Many thanks to #OCRA Silver Sponsor: PharmaLex #OCRA2024 #PharmaLex #Networking #RegulatoryAffairs #WelcomeReception

🌟 New #Job Alert: Specialist, Regulatory Affairs 🌟 Hello #OCRA community! We’d like to share that Edwards Lifesciences Lifesciences is seeking a Regulatory Affairs Specialist to maintain approvals for Class III implantable products, prepare submission documents, and provide regulatory guidance. For more details, visit: https://lnkd.in/gM2hEgE4 #JobAlert #RegulatoryAffairs #MedicalDevices #CareerOpportunity #OCRA

🌟 New #Job Alert: Senior Manager, Global Regulatory Strategy – Medical Devices🌟 Hello #OCRA community! We’d like to share that Allergan Aesthetics, an AbbVie company, is looking for a Senior Manager, Global Regulatory Strategy to lead their US regulatory affairs for device development projects. Some of the Key Responsibilities: - Develop and execute US regulatory strategies - Lead communication with FDA - Collaborate with global regulatory teams - Ensure regulatory compliance For more details, visit: https://lnkd.in/gxAga4ep #JobAlert #RegulatoryAffairs #MedicalDevices #CareerOpportunity #OCRA

🌞🍹 RSVP Now for #OCRA Summer Social Happy Hour!🍹🌞 Join Orange County Regulatory Affairs Discussion Group this Friday to unwind and connect at our #SummerSocial #HappyHour! Enjoy a relaxed evening with great company and refreshing appetizers and drinks! Plus, you'll have a chance to win exciting prizes in our raffle - including #Free registration to the #OCRAAnnualConference! 📅 Date: Friday, July 12 🕒 Time: 4pm-8pm PT (join anytime!) 📍 Location: Bosscat Kitchen & Libations (18169 Von Karman Ave, Irvine) ➡️ RSVP: https://lnkd.in/g-Jxy2XH #OCRA Diamond Sponsor: Allergan Aesthetics, an AbbVie company #SummerSocial #HappyHour #Networking #OCRA

Orange County Regulatory Affairs Discussion Group is thrilled to announce that our Net Promoter Score (NPS) has reached an outstanding 76! An NPS of 76 means that attendees of our educational programs are highly likely to recommend #OCRA to others, demonstrating their trust and satisfaction with our work. This score is a testament to the dedication and hard work of our team and all the speakers who have presented in our 8 monthly educational programs in the past 6 months, and it reflects the strong relationships we’ve built with our audience and members. A big THANK YOU to our amazing members and audience for their continued support and feedback. Your input helps us improve our programs continuously. To our fantastic speakers and team, this achievement is a direct result of your passion, commitment, and expertise! Samantha Eakes, MPH, Heather S. Rosecrans, Grace Fu Palma, Yan Sheng, Magda Michna, PhD, Laura Schall, Eric Henry, Julie Manchester, Richard DeRisio, Sara Yazdanfar, Huong Huynh Reagan, Ronald Kao, Bert Lao, Andrew Shaoyu Chen, Rita De Rama, Sindhu Sridhar, Eric F., Erin Sunga, Bani Tchekanova, PhD #OCRA is committed to providing more helpful and engaging educational programs for the rest of the year and beyond. In addition, if you have not registered for the #OCRAAnnualConference, register today! https://lnkd.in/gMEYefwY. We have such a strong speaker lineup this year - you would not want to miss it! #OCRAdg30 #EducationalProgram #OCRAAnnualConference

RSVP at https://lnkd.in/gUghNSdD #OCRA #SummerSocial #HappyHour #Networking