Systems Ally

🇺🇸 𝐇𝐚𝐩𝐩𝐲 𝐈𝐧𝐝𝐞𝐩𝐞𝐧𝐝𝐞𝐧𝐜𝐞 𝐃𝐚𝐲 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐭𝐞𝐚𝐦 𝐚𝐭 Systems Ally 🎆 We're passionate about medical devices, pharma, biotech, healthcare, automotive, semiconductor and tech industry. Wishing everyone a day filled with celebration and freedom. #IndependenceDay #SystemsAlly

This Memorial Day, we pause to remember and honor the brave men and women who have made the ultimate sacrifice for our country. Systems Ally As a consulting, staffing, and recruiting firm specializing in medical devices, pharma engineering, and regulatory affairs, we deeply appreciate the values of dedication and service. While we work tirelessly to connect top talent with leading companies in the medical and pharmaceutical industries, we are mindful that our freedoms and opportunities are protected by those who serve in the armed forces. Today, we extend our gratitude to all service members and their families. Let us reflect on the true meaning of Memorial Day and remember those who have given everything. #memorialday #2024

The future of biotech isn't AI, then what is it? Continue reading... Regeneron's CEO recently emphasized the transformative potential of gene therapy in biotechnology. In an insightful CNBC article, the CEO discusses how gene therapy is poised to revolutionize the industry. Here's a concise summary to engage our LinkedIn community: 🧬 Unlocking Biotech's Future: Regeneron's CEO highlights gene therapy as the upcoming frontier in biotechnology, with the potential to revolutionize medical treatments. 💡 Innovation at Regeneron: The article sheds light on Regeneron's commitment to innovation, positioning itself at the forefront of groundbreaking advancements in gene therapy. 🔗 Read the Full Article: Dive deeper into the details by checking out the complete CNBC article here: https://lnkd.in/gSGP-mBt 🌐 Join the Conversation: What are your thoughts on gene therapy's impact on 'biotech'? Share your insights and engage with fellow professionals. Please like the post and comment below. For weekly updates and jobs in "Pharma", "Medical Devices" and "Biotech", please follow us!

Honoring the legacy of Martin Luther King Jr. today and every day. His vision for equality and justice continues to inspire positive change. #MLKDay #equalityforall

𝐉&𝐉 𝐭𝐨 𝐏𝐮𝐫𝐜𝐡𝐚𝐬𝐞 𝐓𝐮𝐦𝐨𝐫-𝐀𝐧𝐭𝐢𝐛𝐨𝐝𝐲 𝐁𝐢𝐨𝐭𝐞𝐜𝐡 𝐀𝐦𝐛𝐫𝐱 𝐟𝐨𝐫 $2 𝐁𝐢𝐥𝐥𝐢𝐨𝐧 Johnson & Johnson (J&J) has recently announced its acquisition of Ambrx Biopharma Inc. for a significant sum of $2 billion in cash. Ambrx Biopharma, a San Diego-based biotechnology company, is known for its development of targeted drugs for cancer, particularly tumor-antibody biotechnology. This strategic move by J&J aims to bolster its portfolio with promising targeted cancer therapies. The deal includes gaining access to Ambrx Biopharma's pipeline of drugs designed to target tumors, making it a valuable addition to J&J's efforts in advancing cancer treatment. The acquisition reflects the pharmaceutical giant's commitment to expanding its capabilities in the oncology field. This announcement comes as part of J&J's broader strategy to invest in innovative therapies and technologies that address critical healthcare needs. The targeted cancer therapy developer, Ambrx, with its expertise in antibody-drug conjugates, aligns with J&J's mission to enhance patient outcomes in the realm of oncology. The $2 billion acquisition signifies a substantial investment by J&J in the pursuit of cutting-edge cancer treatments, showcasing the company's dedication to making advancements in the field of biopharmaceuticals. 🌟 Follow & Connect with us Systems Ally for weekly updates and exciting job opportunities in the 🏥 medical devices, 💊 pharma, 🔬 biotech, and 🌐 tech industries! 💼✨ Comment below to receive more information on these amazing opportunities! 🚀 #CareerGrowth #JobAlerts #StayConnected 🤝

The FDA has been working towards harmonizing its 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐒𝐲𝐬𝐭𝐞𝐦 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 (𝐐𝐒𝐑), 21 𝐂𝐅𝐑 𝐏𝐚𝐫𝐭 820, with the international standard 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦𝐬 𝐈𝐒𝐎 13485. This alignment aims to streamline regulatory requirements for medical devices. Here's a brief overview with the latest updates for 2024: 𝐁𝐚𝐜𝐤𝐠𝐫𝐨𝐮𝐧𝐝: The FDA proposed amendments to 21 CFR Part 820 in February 2022, intending to harmonize it with ISO 13485. The new regulation, known as Quality Management System Regulation (QMSR), will incorporate ISO 13485 requirements. 𝐓𝐢𝐦𝐞𝐥𝐢𝐧𝐞: The FDA is on track to release the final rule in December 2024, signifying the culmination of efforts to align with ISO 13485. This harmonization aims to enhance global regulatory consistency. 𝐎𝐧𝐠𝐨𝐢𝐧𝐠 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭𝐬: As of November 2023, the finalization of non-harmonized regulations for combination products is pending. In 2024, FDA is still expecting to finalize a rule updating its Quality Management System Regulation, which aims to harmonize 21 CFR 820 to the ISO 13485 standard. The FDA's commitment to aligning with international standards reflects a broader effort to ensure the safety and effectiveness of medical devices in the global market. 🌐 Follow and Connect with Us for Weekly Updates in Medical Devices, Pharma, Biotech, and Tech Industry. 💡 Please Comment Below to Get Additional Information on the Above Topic.