We're #hiring a new Regulatory Affairs Specialist - Medical Device in United States. Apply today or share this post with your network.
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Why apply for a Regulatory Affairs Manager position with this medical device company? Impactful work: You would work with a wide range of products, from single-use disposable items to more complex medical equipment, offering the opportunity to contribute directly to patient care and the healthcare system. Industry expertise: This is a well-established and respected company in the medical device industry with over 50 years of experience. Working there provides an opportunity to gain valuable experience and knowledge within a reputable organization. Product portfolio: They manufacture and distribute a diverse range of medical devices across various clinical categories. This variety will expose you to different regulatory pathways and challenges, making the work more engaging and broadening your skills. Contribution to a Canadian company: This is a Canadian-owned company with a strong presence in the Canadian and US healthcare markets. BOTTOM LINE: A challenging and rewarding career in a vital industry with a reputable company. Interested? https://ow.ly/Sbqs50UFMFA #careers #hiring #medicaldevices #regulatoryaffairs #qualityassurance
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Why apply for a Regulatory Affairs Manager position with this medical device company? Impactful work: You would work with a wide range of products, from single-use disposable items to more complex medical equipment, offering the opportunity to contribute directly to patient care and the healthcare system. Industry expertise: This is a well-established and respected company in the medical device industry with over 50 years of experience. Working there provides an opportunity to gain valuable experience and knowledge within a reputable organization. Product portfolio: They manufacture and distribute a diverse range of medical devices across various clinical categories. This variety will expose you to different regulatory pathways and challenges, making the work more engaging and broadening your skills. Contribution to a Canadian company: This is a Canadian-owned company with a strong presence in the Canadian and US healthcare markets. BOTTOM LINE: A challenging and rewarding career in a vital industry with a reputable company. Interested? https://ow.ly/9qwi50UFMFF #careers #hiring #medicaldevices #regulatoryaffairs #qualityassurance
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The Role of Regulatory Affairs in Driving Innovation in Life Sciences Regulatory affairs might not be the first thing that comes to mind when you think about innovation, but it plays a crucial role in the success of life sciences companies. Far from being a barrier, a well-rounded regulatory affairs team ensures that new products navigate the complex web of global regulations smoothly, speeding up the path from the lab to the market. When approached strategically, regulatory compliance can actually drive innovation by setting clear pathways and standards. For hiring managers, this means looking for candidates who not only understand the regulatory landscape but also possess a proactive mindset. The best regulatory affairs professionals are those who can anticipate challenges and work closely with R&D, clinical, and marketing teams to align regulatory strategies with business goals. They become key players in ensuring that innovative products meet safety and efficacy standards while staying competitive. Collaboration is key here. Regulatory affairs teams that work in silos risk slowing down the development process. By fostering a collaborative environment, hiring managers can ensure their regulatory teams are actively contributing to innovation. Regular cross-functional meetings and open lines of communication are simple but effective ways to integrate regulatory perspectives early in the product development lifecycle. Ultimately, the right regulatory affairs team can be a major asset in driving innovation. By hiring professionals who see compliance as an opportunity rather than a hurdle, life sciences companies can bring groundbreaking products to market more efficiently, benefiting both the business and the patients they serve. Linkfield Life Sciences
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Navigating complex regulatory requirements in the Medical Devices industry is critical. Compliance and regulations vary dramatically by region and product type. A deep understanding of FDA, EMA, and other regulatory bodies is crucial for ensuring compliance and accelerating product timelines. Leaders with regulatory expertise help avoid costly delays and maintain trust in the market. Looking for your next leader astute in regulatory affairs - Let Cerca Talent take the guess work out of your hiring. #MedicalDevices #RegulatoryCompliance #Leadership #LifeSciences
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Unfortunately I find myself in the position of being unemployed from next March and so I am reaching out to my network in case anyone is looking for a brilliant (if I do say so myself) senior regulatory affairs expert with broad experience across industries and a creative attitude towards finding regulatory solutions! It’s not the ideal time of year for it; but hoping to go into 2025 with my best foot forward. #fmcg #consumerhealth #regulatoryaffairs #cosmetics #medicaldevices
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🚀 Wanted to outline some amazing Quality and Regulatory roles for my network!! 🚀 🌟 Regulatory Affairs Specialist - Medical Device 🌟 Quality Control Manager - Diagnostics 🌟 Regulatory Specialist - Medical Device/Mental Health 🌟 Quality Control Analyst - Diagnostics 🌟 Quality Engineer - Medical Device If you are on the look out for a new role or just want to discuss further feel free to pop me a message! #hiring #quality #regulatory #medicaldevice #iso13485 #pharmaceutical #qualitycontrol #qualityassurance #13485 #QMS #diagnostics
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Want to find out more about the role of Regulatory Affairs Specialist? Take a look at this article where we explore the key responsibilities in this role, the benefits of this career path, and share insights into how the role is evolving: https://buff.ly/44Kf6zv #regulatoryaffairs #regaffairs #regaffairsjobs #lifesciencejobs #jobfocus
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Want to find out more about the role of Regulatory Affairs Specialist? Take a look at this article where we explore the key responsibilities in this role, the benefits of this career path, and share insights into how the role is evolving: https://buff.ly/44Kf6zv #regulatoryaffairs #regaffairs #regaffairsjobs #lifesciencejobs #jobfocus
What Does a Regulatory Affairs Specialist Do?
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Regulatory Affairs and Quality are the cornerstone of the medical device industry. The proactive role of regulatory teams in identifying and mitigating risks can prevent adverse events and protect patient well-being. 𝟭. 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: Regulatory professionals stay current with evolving regulations from authorities like the FDA, EMA, and other global bodies. They ensure that devices meet necessary requirements, covering design controls, labeling, clinical trials, and post-market surveillance. 𝟮. 𝗘𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗦𝗮𝗳𝗲𝘁𝘆: By working closely with product development and quality assurance teams, regulatory affairs experts assess and mitigate risks, ensuring devices are safe and effective. Adhering to regulatory standards helps prevent adverse events and product recalls, protecting patient well-being. 𝟯. 𝗙𝗮𝗰𝗶𝗹𝗶𝘁𝗮𝘁𝗶𝗻𝗴 𝗠𝗮𝗿𝗸𝗲𝘁 𝗔𝗰𝗰𝗲𝘀𝘀: These professionals assist in obtaining regulatory approvals and clearances needed to bring devices to market. They manage submissions such as 510(k), PMA, and CE marking documentation. Accurate and timely submissions expedite market access, bringing devices to patients efficiently. 𝟰. 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: Operating in multiple countries requires navigating complex regulatory landscapes. Regulatory affairs professionals ensure compliance with varying jurisdiction-specific requirements, harmonizing strategies for global market expansion. 𝟱. 𝗣𝗼𝘀𝘁-𝗠𝗮𝗿𝗸𝗲𝘁 𝗦𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗥𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴: After commercialization, regulatory affairs oversee surveillance activities, monitoring adverse events and complaints. They report safety-related information to authorities, ensuring ongoing device safety and compliance throughout the product lifecycle. 𝟲. 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 (𝗤𝗠𝗦): Collaboration with quality management teams is vital to establish and maintain effective QMS per regulatory requirements like ISO 13485. Regulatory professionals ensure processes for design control, risk management, document control, and supplier management are in place, crucial for maintaining product quality and compliance. Regulatory Affairs and Quality professionals are vital for the medical device industry, ensuring regulatory compliance, safeguarding patient safety, and facilitating market access. Their expertise in navigating regulatory landscapes and maintaining quality standards is essential for the success of medical device companies and the health of patients relying on these devices. If you are working within Regulatory Affairs or Quality in the Medical Device Industry, then I would be keen to connect, drop me a message to see how I can support you in your job search. #MedicalDevices #RegulatoryAffairs #PatientSafety #QualityManagement #HealthcareInnovation #Compliance #MedicalIndustry
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🔷 People overcomplicate looking for an entry level regulatory affairs role🔷 Listen, if you are trying to break into regulatory affairs Avoid: • Sending your general CV out • Not applying for enough roles • Not understanding what you are applying to • Applying for regulatory roles that require experience • Obtaining a qualification that doesn't enhance your career prospects • Gaining experience not relevant to regulatory affairs or the pharmaceutical industry Instead: • Sign up to a regulatory affairs introductory course • Obtain regulatory affairs work experience • Tailor your CV towards regulatory affairs • Start applying to many roles Focus on this for two months You will see the difference. 🔷 Get FREE regulatory resources and find out how you can get an entry level job in regulatory affairs🔷 https://lnkd.in/eiS5ft3m 🎁 To get £200 off the Introduction to Regulatory Affairs Course: • Like • Comment 'regulatory' • Connect with me Registration for the November cohort will end this Saturday,16th November #regulatoryaffairs #regulatorytrainingcourses #regulatorycourses #regulatoryworkexperience #entrylevelregulatoryaffairsjobs #regulatoryaffairscertification #regulatoryaffairstraining #Howtogetajobinregulatoryaffairs
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