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Is it possible to manage both Regulatory Affairs and Quality Assurance on your own in a Medical Technology company?   I’ve spoken to a few people in the market lately who have turned down such positions, expressing concerns about the workload being too demanding for one person.   Other professionals in the industry have left solo Head of RA/QA positions within the first year due to unmet promises of team expansion, the overwhelming workload, or the desire to get back into a team leadership role.   Separate RA and QA functions boost efficiency and ensure better risk management, comprehensive compliance, and continuous improvement. This structure ensures regulatory and quality goals are effectively met, resulting in safe, compliant, high-quality products.   Solo roles combining RA and QA might not be sustainable in the long run. While it could work in smaller companies with simpler products, growth or dealing with complex regulations might require team expansion to avoid overwhelming workloads.   Regulatory requirements vary across markets, which can make it challenging for one person to ensure compliance everywhere.   When considering combined RA/QA roles, assess your expertise and capacity. Also, consider the company's commitment to building dedicated teams. Solo roles might lack sustainability, so it's essential to weigh these factors against your skills and career objectives. #regulatoryaffairs #qualityassurance #medicaltechnology #compliance #medtech #medicaltechnology #medicaldevices #RAQA

Real-time feedback from Med-Tech/SaMD #Regulatoryaffairs & #Quality Executives in the last 2 weeks. I'm currently working on an Executive RA/QA role in Digital Health & as a result I've been having many conversations with leaders from the industry. Here's the top reasons why they are telling me they'd be open to change: -Stagnant innovation -Lack of resources (promised budget to hire, but no follow-through) -Lack of funding -Change in strategic direction of the organization -RA/QA strategic input not valued -Desire to take on greater responsibility -Career stagnation (doing the same thing for too long) If you're a Med-Tech leader in: -Regulatory -Quality -Clinical -Market Access/Reimbursement reading this like it's you whom I'm speaking of We'd be happy to do our best to help catalyze your career. Simply send me a DM or email to mitch@theanthonymichaelgroup.com -MR 𝐏𝐒 The Exec RA/QA role in Digital Health that I speak of above is moving quickly...if you're in SaMD as a VP, Sr Director or Director & you want the specifics, don't delay reaching out. #2candidates10days #medtechtalentlab #medicaldevices #medtech #recruiting #hiring #interviewing #theanthonymichaelgroup

For those interested

#hiring Quality Assurance Specialist, Austin, United States, fulltime #jobs #jobseekers #careers #Austinjobs #Texasjobs #ScienceTechnology Apply: https://lnkd.in/gYxDRaXN Job Description Quality Assurance Specialist Job Description Maintain a safe, fast-paced, and positive laboratory environment. Interact directly with clients on an as-needed basis. Assist in training of other personnel as requested. Ensure safety and compliance with governmental regulations. Interact with FDA and clients as needed in the event of an inspection/audit. Follow all applicable Good Clinical Practice Regulations. Generally monitor studies to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with Good Clinical Practice Standards. For any given study, be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Conduct inspections and maintain records or inspecting studies at adequate intervals and maintain written and properly signed records of each analytical/in-phase or periodic inspection. Report any problems which are likely to affect study integrity to the Principal Investigator and Management immediately. Maintain a copy of a master schedule of all studies, include all pertinent information. Maintain copies of all protocols pertaining to all studies for which the unit is responsible. Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. Review all Adverse Events and Serious Adverse Events reported. These are reviewed for accuracy, completion, and ensured to be communicated to the Study Sponsor and IRB

Hello LinkedIn Family! 🌟 Wishing you all a fantastic time as we dive into year-end tasks and extend early Christmas cheer!🎄 For those who've known me from my Pharmacy days and professional journey, your support has been invaluable. As we navigate both professional and personal growth, the pursuit of potential and self-motivation remains key. Recently, I've noticed a limited number of openings in the medical devices complaint handling division. Are any of you facing similar challenges in finding opportunities? I want to bring your attention to a transition I am exploring for professional growth. As a Medical Device Safety Officer, I bring substantial experience in: Complaints Investigator: Conducting thorough investigations, preparing technical summaries for product failures, and collaborating across teams. Analyzing data, drafting MedWatch reports for FDA submission, and contributing to trending analyses for continuous improvement. Complaints Evaluator: Evaluating medical device data, identifying and adding failure or defect allegations. Determining if failures represent adverse events/reportable defects and escalating to the FDA when necessary. Global Complaint Handling.Managing the global complaint handling process, evaluating customer feedback, and interacting with stakeholders for comprehensive data gathering. I'm on the lookout for new opportunities, and your references, job leads, or insights into skill-up programs would be greatly appreciated. Let's connect and explore the possibilities together! 🚀 #CareerTransition #MedicalDevices #ProfessionalGrowth #drugsafety #medicaldevices #regulatoryaffairs

I am open to relocation for the right role and the right company. Just in case you didn't know. I am skilled at managing clinical studies and working cross functionally with all departments and stakeholders. This skill set includes: - QC/QA and managing data reviews, protocol deviations and CAPAs when necessary - eTMF management and regulatory filing - training staff on how to conduct patient visits and clinical trials while maintaining GxP practices - implementing workflows that have increased efficiency by nearly 60% - leading teams at multiple site locations while building them up for future growth and development - patient recruitment project management and coordinating community outreach methods - effective, timely and clear communication to all stakeholders. -preparing for and passing FDA Audit with 100% compliance. And so much more because I'm adaptable. I'm smart. I'm eager. I'm capable. I have done so much more than what is listed above because I have grown and developed a robust amount of knowledge and skills while advancing in this field. I can bring good things to your team by providing quality and exceptional work while also supporting and motivating your teams to further excel. All I ask in return is to work for a good and fair company that will allow me the opportunity to grow long-term. #hireme #clinicalresearch #clinicaltrials

There are pharma and biotechs out there spending too much time looking for a quality director or VP. The truth is, now is as good a time as ever to hire directly - IF you have the network, in-house infrastructure, and strong enough brand proposition to do it efficiently. But a lot of companies don’t have this. And they’re falling into a trap of thinking the perfect candidate will come along…and in the process, are turning away talent individuals, very well suited for their role. Over time, good candidates will get snapped up and the companies that don’t make decision quickly enough will lose out. This inevitably leads to the leadership questioning whether they actually need a quality leader and sometimes end up giving up on the position. Which then leads to frustration, over-worked staff, lack of clarity, and compliance issues. One solution is an interim consultant. We’ve supported three clinical stage biotech’s across the US East Coast this year with interim Heads of Quality. Quality is business critical. Whether it’s a leadership position or not, don’t sit on gaps in QA or QC for too long. The cost of an interim will be far less than the price you pay for the inevitable headache later down the line.

🔍 Are you passionate about improving patient safety and regulatory compliance in the medical device and healthcare industry? We have exciting opportunities for MDR Vigilance Experts/Specialists! for #Hyderabad. Engineering Manager MDR – 20+ years     Understanding Complaints from the Customer's Perspective Record Keeping and Evaluation: Determining Reportability: Investigation and Documentation: Conduct thorough investigations and document findings based on technical product analysis. Ensure record documentation adheres to internal policies and stays audit-ready. Collaboration and Technical Expertise: Collaborate with various departments within - MITG and external stakeholders such as customers and vendors. This collaboration fosters a comprehensive understanding of complaints. Risk Management and Compliance: Review and interpret risk management documentation to effectively handle complaint events. Ensure compliance with FDA and international regulations. Closing: Share your experiences and tips in the comments below. How do you approach complaint management in your industry?     🚀 Myth: Only individuals with Engineering or Science degrees can work in quality assurance or regulatory roles in the medical or pharmaceutical industry.   🔍 Fact: - A Bachelor's degree in Engineering or Science is preferred, but not the only option - Transferable skills such as strong writing abilities and computer literacy are highly valued. - Verbal and written communication and teamwork skills are essential for success in these roles. - Understanding the functionality and intended use of complex medical devices can be learned on the job.   ❌ Don't limit yourself based on your degree. Emphasize your transferable skills and willingness to learn, and you can excel in quality assurance or regulatory roles in the medical or pharmaceutical industry. 💪 #regulatoryaffairs #regulatorycompliance #medicaldevices #MedDevReg #FDARegulation #ISO13485 #MDR #QualityManagement #RegulatoryCompliance #MedicalDeviceSafety #PremarketApproval #PostMarketSurveillance #MedicalDeviceIndustry #MedicalTechnology #ComplianceManagement #complaintshandling #investigation #research Kindly share your CV at - aayush.gupta@weareams.com

🔍 Top 3 Skills Required for Quality Engineer Job in Medical Device Industry 🔍 Are you aiming for a career as a Quality Engineer in the dynamic and impactful Medical Device industry? Here are the top 3 skills you need to succeed: 1.    Regulatory Knowledge 📜 Understanding FDA, ISO 13485, and other regulatory requirements is crucial. Staying updated with compliance standards ensures the safety and efficacy of medical devices. 2.    Analytical Skills 🔍 Strong problem-solving abilities and proficiency in data analysis are essential. These skills help in identifying potential issues and implementing effective solutions to maintain quality. 3.    Attention to Detail 🧐 Precision and thoroughness are key. A meticulous approach ensures that every aspect of the device meets high-quality standards, reducing the risk of defects and enhancing patient safety. Develop these skills to excel and make a meaningful impact in the Medical Device industry! #Hiring #Medicaldevice #QualityEngineer #GroveTechnicalResources

Thrilled to complete a certification in medical device development, focusing on managing the process and ensuring compliance with design control requirements. 🎓🌐   Benefits for my Regulatory Affairs (RA) and Quality Assurance (QA) roles:   Regulatory Compliance: Deep dive into design control requirements for seamless navigation in both RA and QA. Stakeholder Management: Enhanced collaboration in cross-functional teams and with regulatory authorities. Risk Mitigation: Proactively addressing regulatory risks in both RA and QA aspects of development. Documentation Mastery: Ensuring compliant documentation from Design Input to Validation for submissions and audits in both roles. Clinical Evaluation & Investigation: Effective contribution to critical phases in medical device development within RA and QA contexts. Design Transfer & Changes: Mastery in processes for smoother transitions and adaptation to evolving regulatory requirements in both roles. Budgeting and Planning: Insights into estimating project activities and managing budgets for regulatory compliance within resource constraints for both RA and QA functions.   Excited to apply these learnings, contributing to compliant and innovative medical device development in both RA and QA capacities! 🌟💉    #CertificationAchieved #RegulatoryAffairs #QualityAssurance #MedicalDevice #ContinuousLearning #projectmanagement