47 Fda Regulations Jobs - Page 2

This role requires you to be highly skilled in technology transfer of Injectable products to manufacturing plants, including scale-up activities and demonstrating technical capabilities. You will play a key role in ensuring accessibility to both current portfolio and pipeline products. Additionally, you will share responsibility for achieving targeted product execution goals within the department/organization. Your duties will involve documentation, evaluation, and monitoring of batches at the manufacturing site. Your responsibilities will include performing product transfer activities for sterile products as assigned by the Manager/Senior Manager/Designee. You will be involved in the execut...

As a Senior Medical Writer at Syneos Health, you play a vital role in leading the clear and accurate completion of medical writing deliverables. Your responsibilities include managing medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. You will be responsible for completing various documents such as clinical study protocols, reports, patient narratives, annual reports, and more. Adhering to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, and client standards, is essential. Your role involves coordinating quality and editorial reviews, ensuring...

I'm sorry, but I couldn't find any Job Description in your input. Could you please provide the Job Description for me to analyze ,

As the Head of Quality and Regulatory Compliance at the India Innovation Center (IIC) in Bangalore, India, you will play a crucial role in leading the Quality and Compliance Groups within the organization. Reporting to the Supervisor Director Quality and Compliance Critical Care, you will be an integral part of the leadership team at Getinge India. Your primary responsibility will be to ensure the effective establishment and maintenance of quality systems in the projects executed at IIC. You will be tasked with providing strategic leadership and management for the Quality Systems at the IIC, developing a competent and accountable Quality organization aligned with business objectives and comp...

You have an opportunity as a Warehouse and Logistics Manager where you will be responsible for overseeing warehouse operations, inventory control, team management, safety compliance, and logistics and supply chain management in the pharmaceutical/API sector. Your key responsibilities include managing warehouse operations such as receipt, storage, and dispatch of materials, optimizing warehouse layout for efficiency, implementing inventory tracking systems, maintaining accurate inventory records, ensuring compliance with regulatory standards, and supervising warehouse staff. You will also be involved in coordinating with QA/QC for proper material handling, conducting training programs on safe...

As an employee at Advarra, you will be part of a passionate team dedicated to making a difference in the world of clinical research and advancing human health. With our rich history in ethical review services and innovative technology solutions, we are leading the industry in breaking down barriers and accelerating trials. Your role will be crucial in developing and maintaining internal budgets for clinical trial sites, negotiating budgets with sponsors and CROs, and ensuring compliance with regulations and industry best practices. You will play a key role in the development and approval of internal budgets, redlining budgets based on coverage analyses for new studies, and capturing all nece...

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the product lifecycle through obsolescence. Your responsibilities will include assessing changes made to the device post-launch to determine the regulatory impact of these changes on current clearance. You will ensure regulatory compliance by conducting thorough assessments and submitting the necessary documentation for product clearances and approvals from regulatory bodies such as the FDA and Notified Bodies. In this role, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based on regulatory changes. You wil...

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagno...

You are seeking a Lead Engineer - System Verification to join our team. In this role, you will be responsible for executing verification tests, developing test methods, analyzing measurement data, and reporting test results in compliance with international standards. Your tasks and responsibilities will include translating requirements into verification plans and protocols with a focus on traceability. You will develop reproducible and maintainable verification test methods, test set-ups, and tools. It will be your responsibility to define and document the impact on system-level behavior resulting from design changes and ensure thorough verification. You will create, implement, and enhance p...

You will be joining a staffing company specializing in providing top talent to the Medical Device, Pharmaceutical, and Engineering industries as a Bench Sales Recruiter. Your role will involve conducting bench sales for professionals in these industries, focusing on job titles such as Quality Engineer, Manufacturing Engineer, Validation Engineer, and Regulatory Engineer. Building and maintaining relationships with existing clients and vendors, as well as acquiring new business opportunities, will be key responsibilities. You will need to stay updated on industry trends and regulatory requirements, and assist in the preparation of resumes for potential clients. To excel in this role, you shou...

ValGenesis is a leading digital validation platform provider for life sciences companies, catering to 30 of the top 50 global pharmaceutical and biotech companies. ValGenesis plays a crucial role in enabling digital transformation, ensuring total compliance, and enhancing manufacturing excellence/intelligence throughout the product lifecycle. As a Senior Validation Engineer at ValGenesis, you will play a vital role in maintaining the compliance and quality of our innovative software solutions designed for the life sciences sector. Your responsibilities will include collaborating with various teams to develop comprehensive validation strategies, creating and executing test cases, and upholdin...

At Medtronic, you can embark on a life-long journey of exploration and innovation, all while advocating for healthcare access and equity for all. Your leadership will be purpose-driven, aimed at removing barriers to innovation in a more interconnected and compassionate world. You will be responsible for both manual and test automation tasks, engaging in Sprint planning, understanding project scope and timelines, and developing automation scripts based on feature requirements. Collaboration with system and software teams is crucial, ensuring adherence to testing protocols and conducting traceability analysis to ensure all requirements are met. Proactively identifying technical limitations and...

As a Medical Writer II specializing in QC of Regulatory Documents at Syneos Health, you will be responsible for compiling, writing, editing, and coordinating medical writing deliverables that present scientific information clearly and accurately. Your role will involve working within and across departments with minimal or moderate supervision to complete a variety of documents such as clinical study protocols, clinical study reports, patient narratives, investigator brochures, and more. You will adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures, while completing medical writing projects on time and within budget. Additionally, y...

As a Medical Writer II (Clinical Trial Transparency) at Syneos Health, you will play a crucial role in compiling, writing, and editing medical writing deliverables. Your responsibilities will include mentoring less experienced medical writers, developing various documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures with minimal supervision. You will review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. Collaboration with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs will be essential to produce ...

As the Regulatory Affairs Manager at Natural Biogenex Pvt. Ltd. (NBPL), you will be responsible for overseeing the regulatory submission processes, ensuring compliance with all applicable regulations, and managing the regulatory strategy for pharmaceutical products. Your role will involve working closely with various departments such as R&D, Quality Assurance, and Marketing to facilitate the development and commercialization of pharmaceutical products. Your key responsibilities will include developing and implementing regulatory strategies for drug development and approval, guiding regulatory requirements and compliance to internal teams, preparing and submitting regulatory documents to heal...

As a key member of the team, you will be responsible for supporting daily DSCSA operations, which include product serialization, traceability, and exception handling. Your role will involve coordinating with internal teams such as QA, IT, Logistics, as well as external partners like CMOs, 3PLs, and wholesalers to ensure accurate product data exchange. In this position, you will play a crucial role in monitoring and investigating DSCSA compliance issues, such as "data no product" and "product no data" exceptions. You will also be responsible for ensuring the accurate and timely submission of T3 data, which includes Transaction Information, Transaction History, and Transaction Statement. A sig...

As a qualified candidate for this role, you should possess a Graduate or Post Graduate degree in Food Science, Technology, Microbiology, Chemical, Process Engineering, or a related field. Your academic background should be coupled with a minimum of 5 years of experience at the Assistant Manager level in Research & Development (R&D), particularly in the areas of Frozen Foods, Ready to Eat, Snacks, and Baking. An ideal candidate would also have a strong understanding and technical know-how of the Frozen Food industry. You should have experience and familiarity with multi-product technology and multi-location/cultural settings, encompassing Production, Quality, and other relevant areas. Your te...

Position Overview: We are seeking a highly qualified and experienced Director Clinical Research to lead and oversee clinical trials and research initiatives within our organization. The ideal candidate will have strong expertise in clinical research, particularly in oncology, and possess a deep understanding of global clinical trial regulations, study design, and execution. This role requires strategic thinking, team leadership, and the ability to manage multiple concurrent research projects in a fast-paced environment. Key Responsibilities: Leadership & Strategy: o Lead and oversee all clinical research activities, ensuring alignment with organizational goals and regulatory requirements. o ...

Working knowledge of relevant global medical device regulations, requirements, and standards, such as ISO 13485, 21 CFR Parts 803, 806, and 820, ISO 14971, the European Medical Device Directive (93/42/EEC), and EU MDR (2017/745). Provide Quality and Regulatory Affairs input to the product development team and manage all QA & RA responsibilities throughout product development, design changes, and post-market surveillance processes. Establish and analyze key performance indicators to evaluate and continuously improve the Quality Management System (QMS). Possess broad experience and apply professional concepts and company objectives to resolve complex issues in creative and effective ways. Prov...

Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. LOCATION: Digwal, Hyderabad REPORTING STRUCTURE: Reports to Global Engineering & Project head & Site he...

Hiring Production Supervisor for a Medical Device Manufacturing company Job Title: Production Supervisor Medical Devices Location: Bengaluru Experience: 5 - 8 Years Department: Manufacturing / Operations Summary of the role: We are seeking a detail-oriented and proactive Production Supervisor to oversee the manufacturing operations of medical devices , with a specific focus on the X-ray tube production line . The role demands strong leadership, technical expertise in high-voltage components, vacuum processing, and precision assembly within cleanroom environments. The ideal candidate will ensure production efficiency, safety, and compliance with ISO 13485 , FDA 21 CFR Part 820 , and Good Manu...

Role & responsibilities Position Summary: We are seeking an experienced Quality Engineer (QE) with a strong understanding of Good Manufacturing Practice (GxP) regulations. The ideal candidate will play a key role in ensuring that our products meet the highest quality standards by supporting manufacturing operations and ensuring compliance with regulatory requirements. The role will require a deep understanding of GxP and the ability to drive continuous improvements in quality systems, processes, and product quality. Key Responsibilities: Lead and support GxP compliance activities, ensuring adherence to FDA, EMA, and other regulatory requirements. Develop, implement, and maintain quality engi...