❕HOT JOB THIS WEEK❕ 📍Cleveland, Ohio Director of Manufacturing Medical Device Manufacturing $125,000 - $150,000 (negotiable) + annual bonus This super exciting role within a Medical Device manufacturing company who have 40% growth plans for 2024 and is now looking for a Director of Manufacturing to join their team. What is on Offer: 🔹 Hybrid work schedule 🔹 State of the art facility 🔹 2 direct reports with aim to grow the team underneath this individual 🔹 Just received substantial funding from a well-known backer in the Med Tech space Looking for: 🔹 Bachelors degree in a related field 🔹 10-20 years of experience in manufacturing Class III In Vitro Diagnostics (IVD) 🔹 5-10 years of management experience 🔹 Strong familiarity with FDA regulations (e.g. 21 CFR 820) and ISO standards (e.g. ISO 13485) Contact Danielle for more information: 📧 danielle@acepartners.co.uk 📞 +1 (917) 231 9311 Danielle Lea #recruitment #newopportunity #jobs #manufacturing #medicaldevices #directorjobs
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When we think about careers in the medical device industry, engineering roles often come to mind first. But did you know that this dynamic sector is seeking a diverse range of talents? 🔍 Beyond Engineering: Quality Assurance Specialists: Ensuring products meet stringent regulatory standards. Regulatory Affairs Professionals: Navigating the complex landscape of healthcare regulations. Sales and Marketing Experts: Bridging the gap between innovative products and healthcare providers. Clinical Research Coordinators: Facilitating the critical testing phase of device development. The medical device industry is booming, and it's not just about designing devices; it's about ensuring they're safe, compliant, and well-received in the market. So, if you're considering a career shift or just starting out, think beyond engineering! #MedicalDeviceIndustry #CareerOpportunities #BeyondEngineering #unitedpharma
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When it comes to deciding whether you should hire a medical device consultant or not, it is essential to create the list of pros and cons. Today, we are going to take you through some of the pros that comes along with hiring #medicaldeviceconsultant. Getting a professional help is always beneficial, especially if it is about regulatory and compliance of your medical device. Their invaluable expertise in regulatory compliance, approvals, product development, and documentation saves you time and costs.💡🔑 Still not convinced? #elexes #elexesmedicalconsulting #medicaldevice #medicaldevices #regulatoryexperts #regulatoryguidance #medicaldeviceconsultant #healthcare #compliance #classifications #regulatory #HealthcareInnovation #FDAStandards #MedicalDeviceRegulations
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Sr. Medical Device Recruiter & Certified Senior Account Manager-15 years of experience networking, career management, and helping medical device companies build world class teams. (443) 921-9021
NOW AVAILABLE! Medical Device experienced Director of Quality (also open to contract) in search of their next career opportunity-background sneak peek: Nearly 20 years of medical device, pharmaceutical and analytical laboratory management experience (21CFR820, ISO13485/14971/17025, MDR, GxP) Experience overseeing quality engineering, inspection, complaint handling, documentation, MDR remediation, supply chain, and material compliance (REACH, RoHS, CalProp65, conflict minerals) teams, including multiple sites in the US and internationally Implemented and maintained multiple QMS through separations, site relocations, acquisitions and mergers, working with C-Suite and investors to develop and execute cross functional quality plans to achieve objectives Management representative in FDA, Notified Body, and Client Audits Experience with single use systems, biomanufacturing, electromechanical medical devices (including EU Class III) and diagnostics, drug delivery devices, and capital equipment Extensive experience with supply chain management during the pandemic in identifying alternative sourcing, qualifying and implementing in production Hands on approach to problem solving, implementing lean, and project managing complex cross functional objectives Developed and mentored junior personnel For more information, Call/Text/EM 443.921.9021 cgrimes@mriglobalmeddevice.com #medicaldevice #medicaldevices #hiring #nowhiring #job #jobs #recruiting #recruiter #cherylgrimes NOTE: For 14 years I’ve been helping medical device companies find great talent, great talent find great companies, and with networking for #quality #qa #ra #regulatoryaffairs #clinicalaffairs #r&d #development #manufacturing #operations #marketing #supplychain and more. People like working with me because I am relationship driven, not transaction driven. We should know each other!
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🚀 Dive Into the Heart of Medical Innovation: Regulatory Affairs Specialist Wanted! 🚀 Are you passionate about making a difference in the world of medical devices? Do you thrive in an environment where precision meets innovation? We have the perfect opportunity for you! Whom We're Searching For (RA Specialist), Bangalore Location 1. Experienced Innovators: 3-5 years in the medical device realm, ready to navigate the complexities of regulatory standards. 2. Regulatory Rockstars: Experts in ISO 13485, and ISO 14971, with a special shout-out to those who can dance through 510(k) preparations and the EU MDR 2017/745 ballet. 3. Detail Detectives: With analytical prowess, an eagle eye for detail, and documentation that's nothing short of legendary. Your Mission, Should You Choose to Accept: 🔍 Be the regulatory force that guides our groundbreaking medical devices from concept to global markets. 📣 Champion compliance, steer regulatory submissions and ensure our products and practices meet the gold standard of medical device regulations. ⌨ Draft, dissect, and deliver the documentation that defines our path to success, from India to the EU and USA. 📄 Act as the regulatory radar, keeping us ahead of the curve on changes and challenges in the global regulatory landscape. Why You'll Love It Here: 🌟 Work with a visionary team on technologies that transform lives. 📈 Accelerate your career in a role where your contributions are critical to our success. 💡 Be part of a culture where innovation thrives and your ideas can take flight. 🌈 Join Us & Shape the Future of Healthcare 🌈 Feeling inspired? Eager to apply your skills to a cause that matters? Reach out with your resume to careers@hrsnavigation.com Let’s explore how your talents can propel our mission forward! #InnovationInHealthcare #RegulatoryAffairs #MedicalDevices #NowHiring #MakeADifference
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Post Marketing surveillance|ISO 13485 FDA Medical Device Regulation For QMS|Medical device vigilance officer|Medical device Complaint Handling
What is DESIGN TRANSFER in medical device? Design Transfer is a process in which the device is transferred from design and development stage to Production stage. Where all the parameters are checked with respect to manufacturing process, work instruction, developing quality control procedures and Testing. This ensures that the medical device is safe and effective and for its intended use and can be manufactured at a scale to meet the patient and healthcare needs. Documents involved in Design Transfer are 1) Design History File (DHF) 2) Device Master Record 3) Manufacturing Process Documentation 4) Quality Control Documentation 5) Labeling and Packaging Documentation 6) Device History Record (DHR) 7) Regulatory Submission Documentation Note: The specific file and documents for design transfer can vary based on the device and regulatory requirement and manufacturing process. 𝐅𝐎𝐋𝐋𝐎𝐖-#AKBARJILANI #linkedin #brainpower #success #linkedinfollowers #guide #LinkedInTalentSolutions #linkedinnews #India #drugsafety #adverseevents #jobseekers #linkedin #pharmacovigilance #drug #medicine #trendingnews #news #health #safety #medical #drugdevelopment #drugproduct #trendingnow #viralpost #job #motivation #motivationalquotes #branding #personalbranding #mindset #selfgrowth #AnthonyGouvouniotis #justsaying #sickleave #officehumor #hr #job #managers #interviewquestions #interviewpreparation #interview #linkedinforcreator #design #medicaldevice #regulatory #quality
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🤔Confused whether to hire a medical device regulatory consultant or not? If yes this post will help you😊 Here are some Pros of Hiring a #MedicalDeviceRegulatory Consultant 💁🏻♀️ Expertise: Consultants bring specialized knowledge of ever-evolving regulatory landscapes, ensuring compliance with industry standards. Efficiency ✅ : Streamline the regulatory process and navigate complex requirements swiftly, saving time and resources. Cost-Effectiveness: Consultants offer a cost-effective 💰 alternative to hiring full-time regulatory staff, especially for short-term projects. Industry Connections: Established consultants often have strong networks, facilitating smoother interactions with regulatory authorities. Risk Mitigation: Reduce the risk of regulatory pitfalls and ensure a smoother path to market for your medical devices. When considering your regulatory strategy, these advantages make a compelling case for the value that a Medical Device Regulatory Consultant can bring to your team! 💼🏥 However, if you still find yourself stuck with this question, you must check our article on Pros and cons of hiring a medical device consultant below 👇🏻 #medicaldevices #medicaldevice #medicaldeviceconsultants #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicedesign #medicaldeviceregulatory #medicaltechnology #medtech #medicaltech #medtechinnovation #medtechinnovator #medicine #healthcare #healthcareinnovation #healthcareforall #regulatoryaffairs #healthcareindustry #healthcaretech #healthcaretechnology
🤔Confused whether to hire a medical device regulatory consultant or not? If yes this post will help you😊 Here are some Pros of Hiring a #MedicalDeviceRegulatory Consultant 💁🏻♀️ Expertise: Consultants bring specialized knowledge of ever-evolving regulatory landscapes, ensuring compliance with industry standards. Efficiency ✅ : Streamline the regulatory process and navigate complex requirements swiftly, saving time and resources. Cost-Effectiveness: Consultants offer a cost-effective 💰 alternative to hiring full-time regulatory staff, especially for short-term projects. Industry Connections: Established consultants often have strong networks, facilitating smoother interactions with regulatory authorities. Risk Mitigation: Reduce the risk of regulatory pitfalls and ensure a smoother path to market for your medical devices. When considering your regulatory strategy, these advantages make a compelling case for the value that a Medical Device Regulatory Consultant can bring to your team! 💼🏥 However, if you still find yourself stuck with this question, you must check our article on Pros and cons of hiring a medical device consultant below 👇🏻 #medicaldevices #medicaldevice #medicaldeviceconsultants #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicedesign #medicaldeviceregulatory #medicaltechnology #medtech #medicaltech #medtechinnovation #medtechinnovator #medicine #healthcare #healthcareinnovation #healthcareforall #regulatoryaffairs #healthcareindustry #healthcaretech #healthcaretechnology
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🤔Confused whether to hire a medical device regulatory consultant or not? If yes this post will help you😊 Here are some Pros of Hiring a #MedicalDeviceRegulatory Consultant 💁🏻♀️ Expertise: Consultants bring specialized knowledge of ever-evolving regulatory landscapes, ensuring compliance with industry standards. Efficiency ✅ : Streamline the regulatory process and navigate complex requirements swiftly, saving time and resources. Cost-Effectiveness: Consultants offer a cost-effective 💰 alternative to hiring full-time regulatory staff, especially for short-term projects. Industry Connections: Established consultants often have strong networks, facilitating smoother interactions with regulatory authorities. Risk Mitigation: Reduce the risk of regulatory pitfalls and ensure a smoother path to market for your medical devices. When considering your regulatory strategy, these advantages make a compelling case for the value that a Medical Device Regulatory Consultant can bring to your team! 💼🏥 However, if you still find yourself stuck with this question, you must check our article on Pros and cons of hiring a medical device consultant below 👇🏻 #medicaldevices #medicaldevice #medicaldeviceconsultants #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicedesign #medicaldeviceregulatory #medicaltechnology #medtech #medicaltech #medtechinnovation #medtechinnovator #medicine #healthcare #healthcareinnovation #healthcareforall #regulatoryaffairs #healthcareindustry #healthcaretech #healthcaretechnology
🤔Confused whether to hire a medical device regulatory consultant or not? If yes this post will help you😊 Here are some Pros of Hiring a #MedicalDeviceRegulatory Consultant 💁🏻♀️ Expertise: Consultants bring specialized knowledge of ever-evolving regulatory landscapes, ensuring compliance with industry standards. Efficiency ✅ : Streamline the regulatory process and navigate complex requirements swiftly, saving time and resources. Cost-Effectiveness: Consultants offer a cost-effective 💰 alternative to hiring full-time regulatory staff, especially for short-term projects. Industry Connections: Established consultants often have strong networks, facilitating smoother interactions with regulatory authorities. Risk Mitigation: Reduce the risk of regulatory pitfalls and ensure a smoother path to market for your medical devices. When considering your regulatory strategy, these advantages make a compelling case for the value that a Medical Device Regulatory Consultant can bring to your team! 💼🏥 However, if you still find yourself stuck with this question, you must check our article on Pros and cons of hiring a medical device consultant below 👇🏻 #medicaldevices #medicaldevice #medicaldeviceconsultants #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicedesign #medicaldeviceregulatory #medicaltechnology #medtech #medicaltech #medtechinnovation #medtechinnovator #medicine #healthcare #healthcareinnovation #healthcareforall #regulatoryaffairs #healthcareindustry #healthcaretech #healthcaretechnology
Pros and cons of hiring a medical device consultant
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I help leaders within Medtech secure the top talent across the US East Coast | Get in touch if you're looking for support!
🔬 Medical Device Recalls 🔬 🔎 Recently I have noticed an increase in the frequency of recalls being issued to multiple Medical Device companies. Looking deeper into the subject I learnt that Medical Device recalls rose 📈 by almost 14% in Q1 of 2024. Here are three effective strategies to help medical device companies in the U.S. minimize recalls: ➡ Enhance Quality Management Systems - A robust QMS is essential for preventing defects and ensuring consistent product quality. ➡ Improve Supply Chain Transparency and Collaboration - Supply chain issues are a common cause of recalls. Improving transparency and collaboration with suppliers can help mitigate these risks. ➡ Invest in Employee Training and Development - Human error often contributes to recalls. Investing in ongoing training and development for employees can significantly reduce this risk. This is also where hiring candidates with the right skillset becomes crucial. Have you noticed a similar trend in the increase of recalls of products and what do you think is the reason behind this? 🤔 #medicaldevice #regulatoryaffairs #qualityassurance #usa #recalls #FDA #recruitment #hiring #jobs
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🤔Confused whether to hire a medical device regulatory consultant or not? If yes this post will help you😊 Here are some Pros of Hiring a #MedicalDeviceRegulatory Consultant 💁🏻♀️ Expertise: Consultants bring specialized knowledge of ever-evolving regulatory landscapes, ensuring compliance with industry standards. Efficiency ✅ : Streamline the regulatory process and navigate complex requirements swiftly, saving time and resources. Cost-Effectiveness: Consultants offer a cost-effective 💰 alternative to hiring full-time regulatory staff, especially for short-term projects. Industry Connections: Established consultants often have strong networks, facilitating smoother interactions with regulatory authorities. Risk Mitigation: Reduce the risk of regulatory pitfalls and ensure a smoother path to market for your medical devices. When considering your regulatory strategy, these advantages make a compelling case for the value that a Medical Device Regulatory Consultant can bring to your team! 💼🏥 However, if you still find yourself stuck with this question, you must check our article on Pros and cons of hiring a medical device consultant below 👇🏻 #medicaldevices #medicaldevice #medicaldeviceconsultants #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicedesign #medicaldeviceregulatory #medicaltechnology #medtech #medicaltech #medtechinnovation #medtechinnovator #medicine #healthcare #healthcareinnovation #healthcareforall #regulatoryaffairs #healthcareindustry #healthcaretech #healthcaretechnology
Pros and cons of hiring a medical device consultant
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➕ Today's 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 features Principal RA/QA Rostislav Stoykov. With a strong foundation in biomedical and clinical engineering, Rostislav has masterfully navigated the complex regulatory landscape and made significant contributions in the medical device industry. Highlights from his conversation with Jaishankar Kutty, Ph.D.: 🎓 𝗕𝗶𝗼𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗮𝗻𝗱 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗘𝗻𝗴𝗶𝗻𝗲𝗲𝗿𝗶𝗻𝗴 𝗥𝗼𝗼𝘁𝘀: Rostislav’s journey began with a dual degree in biomedical and clinical engineering, a remarkable start that set the stage for his multifaceted career. His technical ability laid the foundation for his future successes in product management and RA/QA roles. 🌐 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗟𝗮𝗻𝗱𝘀𝗰𝗮𝗽𝗲𝘀: With roles ranging from leading MDD remediation programs to being the regulatory lead for global legal manufacturers, Rostislav's experience is vast. Perhaps most impressive and as Jai points out in the interview, has been his consistent ability to remain calm and find successful paths in many challenging regulatory scenarios. 🧩 𝗛𝗼𝗹𝗶𝘀𝘁𝗶𝗰 𝗥𝗔/𝗤𝗔 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵: Rostislav emphasizes the inseparability of quality and regulatory aspects in the medical device field. His expertise in both areas has allowed him to tackle comprehensive challenges and implement effective solutions, ensuring the delivery of high-quality, compliant products. Rostislav exemplifies the blend of technical knowledge, strategic thinking, and regulatory acumen that is essential for the highest performance and impact in today's device industry. 𝗧𝗵𝗶𝘀 𝗶𝘀 𝗲𝘅𝗮𝗰𝘁𝗹𝘆 𝘄𝗵𝗮𝘁 𝗥𝗤𝗠+ 𝘀𝘁𝗿𝗶𝘃𝗲𝘀 𝘁𝗼 𝗯𝗿𝗶𝗻𝗴 𝘁𝗼 𝗲𝘃𝗲𝗿𝘆 𝗰𝗹𝗶𝗲𝗻𝘁 𝗮𝗻𝗱 𝗽𝗿𝗼𝗷𝗲𝗰𝘁. RQM+ is proud to have Rostislav as a key member of our team, continually elevating our capabilities and impact in the industry. 🙏 #ExcellenceSpotlight #BiomedicalEngineering #ClinicalEngineering #RegulatoryAffairs #MedicalDevices #GlobalHealthcare #RQMPlus #Innovation #MedTech
Rostislav Stoykov, Principal RA/QA | Excellence Spotlight
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