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      "text": "The ex-employee further alleged that TransMedics has no safety function or even one person in such a role, and that the VP of Global Regulatory Affairs featured on its management team is just “an ornament because she worked at the FDA before...she was never in the office...she was never in the office...she was not really involved with anything...she had never been to Boston...she was living in Washington, DC...she was not really engaged with any of us...we didn't know where she was or what she was doing.”",
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      "text": "The ex-employee further alleged that TransMedics has no safety function or even one person in such a role, and that the VP of Global Regulatory Affairs featured on its management team is just “an ornament because she worked at the FDA before...she was never in the office...she was never really involved with anything...she had never been to Boston...she was living in Washington, DC...she was not really engaged with any of us...we didn’t know where she was or what she was doing.” The ex-employee further alleged that TransMedics had only one person in a safety role but terminated the entire function: “I still talk to a few people at the company...they do not have a safety person...they haven’t hired anyone...it was a one-person operation...doing all safety for all trials and devices.” We conducted a brief LinkedIn search to check, which showed ~900 employees but none with a profile consistent with such a safety role; the search did indicate a handful of clinical and regulatory affairs employees, albeit without any detail suggesting that their roles encompassed safety.",
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      "text": "VP of Regulatory Affairs is allegedly just “an ornament”\nA: “Especially the vice president of regulatory, she was hired, but she was more, so to speak, an ornament because she worked at the FDA before. So, you know, to be able to say on their website that so-and-so used to be at the FDA. But she was never in the office. She may be close to 70 years old, but maybe they were just using her name. She was not really involved with anything. She had never been in Boston. She was living in Washington, DC.”\nQ: “Was she on calls? Was she working? Was she interacting with you or no?”\nA: “Not really. And she was not really engaged with any of us.”\nQ: “Was she working with the CEO?”\nA: “No idea. We didn’t know where she was or what she was doing… I still talk to a few people at the company. They do not have a safety person. They haven’t hired anyone. They haven’t replaced that position.”\nQ: “You said they let go the entire safety team?”\nA: “It was one person. It was a one-person operation who was doing all safety for all trials and all devices.”\nQ: “They only had one safety person the entire time?”\nA: “Yeah.” – Former employee in a regulatory affairs role",
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      "text": "“Especially the vice president of regulatory, she was hired, but she was more, to speak, an ornament because she worked at the FDA before. So, you know, to be able to say on their website that so-and-so used to be at the FDA. But she was never in the office. She may be close to 70 years old, but maybe they were just using her name. She was not really involved with anything. She had never been in Boston. She was living in Washington, DC.” — Former employee in a regulatory affairs role",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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