1256 Mdr Jobs - Page 45

Responsibilities: Primary Responsibilities: 1. Regulatory Filings and Compliance of regulatory documents: • Coordinating for planning and execution of device regulatory submissions and all other regulatory related activities, globally • Responsible to assist in activities of authoring, review, submission of device related sections of different combination products • Responsible for preparing the response and submission for any agency queries information request on device activities. • Responsible for ISO 13485/ CE certification audit compliance pertaining to regulatory activities and contributes towards post audit management. • Responsible for device related sections in post approval variati...

Job Title: QC Analyst I At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagno...

The Product Owner is responsible for the definition and delivery of a part of a product from a customer and market requirement point of view - regarding content, prioritization, quality and customer excitement for a given cost and time frame. Responsible for a part of the product through the product life cycle from the definition to the phase-out. Provides the associated development teams with priorities and expertise regarding the product and ensures completeness and consistency of the derived requirements within the part of the product. Responsible for definition and delivery of a part of a product from a customer and market requirement point of view, working with one or several developmen...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Quality engineer to support PSUR activities for NV OU Careers that Change Lives As a Quality Engineer you will be a key member of the Medtronic Post Market Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. A Day in the Life Prepare and compile product pos...

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quali...

Vice President - Cyber Security Operations Job Statement: NopalCyber makes cybersecurity manageable, affordable, reliable, and powerful for companies that need to be resilient and compliant. Managed extended detection and response (MXDR), attack surface management (ASM), breach and attack simulation (BAS), and advisory services fortify your cybersecurity across both offense and defense. AI-driven intelligence in our Nopal360° platform, our NopalGo mobile app, and our proprietary Cyber Intelligence Quotient (CIQ) lets anyone quantify, track, and visualize their cybersecurity posture in real-time. Our service packages, which are each tailored to a client’s needs and budget, and external threat...

At Armor, we are committed to making a meaningful difference in securing cyberspace. Our vision is to be the trusted protector and de facto standard that cloud-centric customers entrust with their risk. We strive to continuously evolve to be the best partner of choice, breaking norms and tirelessly innovating to stay ahead of evolving cyber threats and reshaping how we deliver customer outcomes. We are passionate about making a positive impact in the world, and we’re looking for a highly skilled and experienced talent to join our dynamic team. Armor has unique offerings to the market so customers can a) understand their risk b) leverage Armor to co-manage their risk or c) completely outsourc...

Prepare, review, and file global premarket documents, collaborate with teams, develop regulatory strategies, and ensure compliance with India, US FDA, and EU regulations for medical devices or pharmaceuticals.

Job Description Job Overview: The Principal Auditor is primarily responsible for guiding the financial, operational, business process or compliance audit towards successful completion at McDermott across the globe. The Principal Auditor effectively interfaces with various levels of management and develops relationships that further the organizational goals. The Principal Auditor should demonstrate high energy, be flexible and innovative and motivated to work in a fast paced and challenging environment that continues to evolve. The position in an individual contributor and reports to Senior Manager, Audit. The Principal Auditor position does not have formal supervisory responsibility for the ...

Job Description Working closely with the Global Regulatory Affairs team, you'll be responsible for planning, scheduling, and managing the preparation and submission of regulatory applications to local authorities, including support for EU MDR submissions and approvals. Ensure all marketed devices secure and maintain necessary regulatory approvals, managing registration processes according to both regulatory guidelines and internal company procedures. Proactively maintain an up-to-date project tracker, ensuring all information is current and accurate. Collaboration with the Business Manager and Dealers is crucial to identify and mitigate potential supply chain risks Completes other regulatory...

Job Title: QARA Lead Experience: 3–6 years Location: Bengaluru, India (IISc Campus) Responsibility : Quality Management System: Architect, implement, and maintain a lean, audit-ready ISO 13485:2016 Quality Management System (QMS). Drive certification and act as Management Representative (MR) for audits and regulatory inspections. Regulatory Strategy & Submissions: Define and execute regulatory strategies for CDSCO (Class II/III), FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Design Control & Documentation: Own all design-control documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collab...

Company Profile Since year 2003, Oceaneering’s India Center has been an integral part of operations for Oceaneering’s robust product and service offerings across the globe. This center caters to diverse business needs, from oil and gas field infrastructure, subsea robotics to automated material handling & logistics. Our multidisciplinary team offers a wide spectrum of solutions, encompassing Subsea Engineering, Robotics, Automation, Control Systems, Software Development, Asset Integrity Management, Inspection, ROV operations, Field Network Management, Graphics Design & Animation, and more. In addition to these technical functions, Oceaneering India Center plays host to several crucial busine...

Job Description– Associate Agency Development Manager job summary : Responsible for  Agent Recruitment  Agent Development  Meet Business targets  Customer Centricity Key Responsibilities: Agent Recruitment  Develop various sources of agent hiring & build a team of agent & agent pipe line.  Conduct activity to enhance existing agent footfall to generate fresh referral for new agent hiring  Implementation of MLI GOLD process and adhere to the business norms  Follow agent 9 pointer hiring mechanism & other hiring norms Agent Development  Ensure product knowledge by MLI ways of training  Field demonstration (FOD’s)  Development of agent prospecting habits, calling habits and work habi...

Position - Senior Manager Location - Noida Education - Graduate or Postgraduate degree/BTech. Professional Qualifications - ISO 13485 Lead or Internal Auditor. EDMS Management or auditing. Role Description – Task and Responsibilities: Act as the lead internal auditor for medical device programs, ensuring compliance with ISO 13485 and U.S./EU regulations. Investigate non-conformances and implement effective corrective actions for medical device-related issues. Review onboarding checklists to ensure FDA and EU MDR requirements are met for all devices. Oversee compliance in shipping, labeling, and depot processes for investigational and commercial devices. Serve as the main contact during ISO 1...

Job Description Job Overview: The Senior Quality Inspector uses best practices and knowledge of internal or external issues to improve the inspection discipline within McDermott. They will act as a resource for colleagues with less experience and share their conceptual and practical expertise related to the inspection discipline. The Senior Quality Inspector solves complex problems and uses discipline-specific knowledge to improve their products or services. The Senior Quality Inspector impacts a range of customer, operational, project, or service activities with the inspection team and other related teams and ensures that they work within the appropriate guidelines and policies. Responsibil...

Operating Company: Kerr Location: Mumbai,Maharashtra,IN Date Posted: June 4, 2025 Req Number: R5022857 Job Description: Working closely with the Global Regulatory Affairs team, you'll be responsible for planning, scheduling, and managing the preparation and submission of regulatory applications to local authorities, including support for EU MDR submissions and approvals. Ensure all marketed devices secure and maintain necessary regulatory approvals, managing registration processes according to both regulatory guidelines and internal company procedures. Proactively maintain an up-to-date project tracker, ensuring all information is current and accurate. Collaboration with the Business Manager...

Summary Data has never been more valuable and vulnerable. As cybercriminals become more sophisticated and regulations more strict, organizations struggle to answer one key question: “Is my data safe?" At Varonis, we see the world of cybersecurity differently. Instead of chasing threats, we believe the most practical approach is protecting data from the inside out. We’ve built the industry’s first fully autonomous Data Security Platform to help our customers dramatically reduce risk with minimal human effort. At Varonis, we move fast. We’re an ultra-collaborative company with brilliant people who care deeply about the details. Together, we’re solving interesting and complex puzzles to keep th...

Responsibilities New product design & development initial stage to production stage. Benchmarking of the product. Test and record performance of components, products & manufacturing methods. Analyze and resolve technical issues associated with components, products, manufacturing methods and performance. Prepare bill of materials (BOM), design specifications & raw materials specifications etc. Conduct failure mode & risk analysis according to ISO 13485. Responsible for product design verification & validation and maintain its records. Ensuring Manufacturing performance and Quality goals are met. Prepare and review documentation history files (DHFs). . Maintain and improve existing product man...

Job Summary : This role to ensure that all sterile medical devices manufactured at the plant meet the highest standards of quality, safety, and compliance. He / She must have strong understanding of regulatory requirements (such as ISO 13485, Indian Medical Device Rule-2017 etc) with respect to inspection & testing, and hands-on experience with quality control processes in a cleanroom or GMP-compliant environment. Key Responsibilities: Supervise the team perform in-process and final inspection of sterile medical devices and components. Conduct sampling, testing, and documentation of raw & packaging materials, finished goods, sales return product, Stability study etc. Involve customer complai...

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a ...

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a ...

Cyderes (Cyber Defense and Response) is a pure-play, full life-cycle cybersecurity services provider with award-winning managed security services, identity and access management, and professional services designed to manage the cybersecurity risks of enterprise clients. We specialize in multi-technology, complex environments with the in speed and agility needed to tackle the most advanced cyber threats. We leverage our global scale and decades of experience to accelerate our clients’ cyber outcomes through a full lifecycle of cybersecurity services. We are a global company with operating centers in the United States, Canada, the United Kingdom, and India. About the Job: We are seeking a high...

Job Description Job Overview: Perform conceptual, FEED, Studies, and detailed analyses and design as per design basis, project specifications, design codes and standards. Direct Engineering team as a Lead Engineer on small projects. Apply knowledge and skills to a wide range of standard and nonstandard situations. Prepare clear and accurate detailed design calculations and analyses including design reports and procedures. Manage own time to meet agreed deadlines and budgets and develop plans for short-term work activities in own area. Clearly communicate and explain complex issues and work to establish understanding. Responsibilities Key Tasks and Responsibilities: Be fully familiar with the...

Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is safer and more secure than the one before. We are a company built on the foundation of challenging and disrupting the way things are done, and we’re looking for innovators who are as committed to shaping the future of cybersecurity as we are. Who We Are We take our mission of protecting the digital way of life seriously. We are relentless in protecting our customers and we believe that the unique ideas of every member of our team contributes to our collective success. Our values were crowdsourced...

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate...