1249 Mdr Jobs - Page 38

Role & responsibilities Preparation, Review and updation of Technical Files as per euMDR 2017/745 & DMF as per IMDR. General performance and safety records as per respective Guidelines. Risk Management plan & reports as per respective guidelines. Clinical Evaluation protocol & Report as per respective Guidelines. PMS,PMCF & PSUR plan & report as per respective Guidelines. Design & Development documentation & report as per respective Guidelines. Usability engineering protocol & report as per respective Guidelines. Track & Trend & report all Re-portable events,including serious/ adverse incidence, field safety corrective Keep up to date with national and international legislation,guidelines an...

Company Description 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 valu...

Job description We Are Hiring Senior Executive - Regulatory Affairs For Medical Devices (Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation For ISO13485, CE Certificate (As Per EU MDR). 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Risk Management as per EU MDR 5. Have Knowledge About QMS (Quality Management Systems). 6. Reporting To Regulatory Authorities. 7. Conducting Internal Quality Audits. 8. Have Experience Or Knowledge Of European CE (MDD & MDR). 9. Have Knowledge Of USFDA 510K. Skill: 1. Documentation Handling 2. Written & Verbal Communicate Skill 3. Have Good Knowledge Of Computer And MS ...

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 Responsibilities may include the following and other duties may be assigned: Analyze returned products to identify failure modes and root causes. Conduct detailed assessments of device performance, including physical inspection and functional testing. Document investigation findings in the complaint handling system, ensuring accuracy and completeness. Review complaint data for trends and recurring issues. Identify opportunities for str...

Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. Desired Candidate Profile: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field. A minimum of 6 years of ...

Job Title Software Design Quality Engineer Job Description Job Title : Software Design Quality Engineer Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. You are responsible for Ensure that appropriate project plan and qua...

Job Location : Chennai Relocation Bonus for Outstation Candidates as per company policy. We are accepting Job Applications : Please submit updated CV - Email : Lamiya.JA@quest-global.com;sunil.chandran@quest-global.com Senior / Firmware Architect - Medical Devices | 10 - 20 Years | Job Description Responsibilities include - Design and architect embedded software systems from concept to production. - Lead and mentor a team of embedded software engineers. - Develop and maintain embedded software architectures and design patterns. - Optimize software for performance, reliability, and power consumption. - Conduct code reviews and ensure compliance with industry standards and best practices. - In...

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 Description Job Overview: The Principal Instrumentation & Controls Eng is responsible for interpreting internal or external business issues and recommending best practices. They will be tasked with solving complex Instrumentation & Controls-related problems and will work independently with minimal guidance. The Principal Instrumentation & Controls Eng may be responsible for leading functional teams or projects and is regarded as a specialist in the field of Instrumentation & Controls. As such, they must have in-depth expertise in Instrumentation & Controls as well as broad knowledge of the Instrumentation & Controls discipline within the Engineering function. Responsibilities Key Tasks a...

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 developme...

ABOUT S3V VASCULAR TECHNOLOGIES LIMITED S3V Vascular Technologies Limited is an ISO 13485 certified company involved in the development and manufacture of Neurovascular, Cardiovascular Medical devices and Critical Care products such as Clot Retrievers, Neuro Aspiration Catheters, Neuro Micro-catheters, Neuro Guide catheters, Drug Eluting Stents, PTCA Catheters and drug coated critical care catheters. S3V is setting up an integrated manufacturing facility in Chennai at the Medical Device Park, Oragadam for the manufacture of Neuro interventional and peripheral interventional devices. With a strong focus on innovation, clinical safety, and regulatory compliance, we are committed to delivering ...

This job is with Amazon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Description Job Description: The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with India Security and Loss Prevention guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve p...

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY-Cyber Security-TDR Senior (OT Lead Analyst – L3) As part of our EY-cyber security team, who shall work as SME for OT/IOT security solutions. The opportunity We’re looking for Senior consultant with expertise in OT/IOT security solutions. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of...

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY-Cyber Security-TDR Senior (OT Lead Analyst – L3) As part of our EY-cyber security team, who shall work as SME for OT/IOT security solutions. The opportunity We’re looking for Senior consultant with expertise in OT/IOT security solutions. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of...

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 As a Principal Project Management Specialist, you will be a key member of the Medtronic Quality Engineering team responsible for maintaining the highest standards of product reliability and patient well-being across the Cranial and Spinal Technologies (CST) Operating Unit. CST provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. Respons...

As the Product Manager for the Cios Fit Platform, you will be the strategic and operational owner of a unique surgery product platform, which is the only one engineered and made in India in SHS. The Cios Fit is a value-segment medical imaging solution designed for intraoperative use across a range of clinical specialties, including orthopedics, surgery and urology. The product is exported from India to 30+ countries and developing the global footprint and expanding the product platform to new clinical applications is key for the success of the platform. You will lead the product strategy, define market and user requirements, drive execution in R&D and SCM aligned with business goals, clinica...

Regulatory Engineer Date: 20 Jun 2025 Location: Bangalore Company: LTTS Job Description - Regulatory Affairs Specialist Support development, preparation, & submission of technical files & regulatory documentation, including 510(k) submissions, APAC regulatory submissions, US FDA and EU submissions, pre submissions, and product registration dossiers for Class I, II, & III medical devices, in compliance with FDA, EU MDR, regulatory requirements, ISO 13485, and global regulatory requirements. Managed documentation for manufacturing line transfer activities and quality assurance, including the preparation and submission of adverse event reports, product safety evaluations, and regulatory impact ...

Engineer - Project Management Sri City, IND Engineer - Project Management Location: Sri City, Andhra Pradesh, India, 517 646 Company: Chart Industries Ensuring Chart’s success VRV Asia Pacific Pvt. Ltd!!!A CHART Industries Company. We are a US Multi-National Company, wedesignand fabricate state-of-the-art vacuum insulated cryogenic storage tanks for the distribution & storage of liquefied gases such as nitrogen, oxygen, argon, LNG (natural gas), hydrogen and other hydrocarbons for use in industrial, healthcare, electronics, food & energy. Our vision , "Providing engineered solutions to enable a better tomorrow” , embodies our commitment to innovation and sustainability. Every decision we mak...

Arni Medica is a leading medical device manufacturer specializing in contract manufacturing, new product development, and high-quality production of nephrology and healthcare products. Key Responsibilities Strategic Leadership: Assume leadership and full P & L responsibility for the respective group/verticals. Prepare annual budget and Track project budgets and timelines. Develop and execute strategic plans to achieve organizational objectives and growth targets. Align operational goals with the company’s vision and mission. Identify and evaluate new business opportunities, partnerships, and market trends. Operations Management: Oversee all aspects of operations, including production, supply...

Location: Sri City, Andhra Pradesh, India, 517 646 Company: Chart Industries Ensuring Chart’s success VRV Asia Pacific Pvt. Ltd!!!A CHART Industries Company. We are a US Multi-National Company, wedesignand fabricate state-of-the-art vacuum insulated cryogenic storage tanks for the distribution & storage of liquefied gases such as nitrogen, oxygen, argon, LNG (natural gas), hydrogen and other hydrocarbons for use in industrial, healthcare, electronics, food & energy. Our vision , "Providing engineered solutions to enable a better tomorrow” , embodies our commitment to innovation and sustainability. Every decision we make contributes to a safer, stronger, and more resilient future for our cust...

It's fun to work in a company where people truly BELIEVE in what they're doing! Job Description Summary: As a cybersecurity engineer focused on cloud security with Rocket Software, you are part of a global, fast-paced IT organization with a primary mission to provide world class service to software development labs and internal departments ensuring our employees have secure access and communication systems to perform at the highest level. The successful candidate will be a highly technical individual with responsibility for the security of company data and workloads in public cloud infrastructure and SaaS platforms. This role will also provide guidance, advice, data and reports on their acti...

It's fun to work in a company where people truly BELIEVE in what they're doing! Job Description Summary: As a cybersecurity engineer focused on cloud security with Rocket Software, you are part of a global, fast-paced IT organization with a primary mission to provide world class service to software development labs and internal departments ensuring our employees have secure access and communication systems to perform at the highest level. The successful candidate will be a highly technical individual with responsibility for the security of company data and workloads in public cloud infrastructure and SaaS platforms. This role will also provide guidance, advice, data and reports on their acti...

It's fun to work in a company where people truly BELIEVE in what they're doing! Job Description Summary: As a cybersecurity engineer focused on cloud security with Rocket Software, you are part of a global, fast-paced IT organization with a primary mission to provide world class service to software development labs and internal departments ensuring our employees have secure access and communication systems to perform at the highest level. The successful candidate will be a highly technical individual with responsibility for the security of company data and workloads in public cloud infrastructure and SaaS platforms. This role will also provide guidance, advice, data and reports on their acti...

Job Description: Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device in Risk management , regulatory Quality systems EU MDR, US FDA and closely working R&D, Regulatory Affairs & design quality organizations Strong proven experience in simplifying/reviewing RMM,BRD, RMF, Trace matrix, DHFs, Design requirements, IFUs, Risk management , V&V activities etc. Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC , ISO. Experience with systems for quality management, product development, and follow-up of procedures Knowledge and application of medica...

Analyze post-market surveillance data from global sources (e.g., MAUDE, FAERS, EUDAMED, internal complaint databases) to detect safety signals and evaluate adverse event trends. Organize and manage complex datasets using appropriate database systems and data structures. Develop dashboards, visualizations, and summary reports for internal and external stakeholders, including support for regulatory submissions. Collaborate with cross-functional teams including safety physicians, data scientists, and regulatory experts to evaluate post-market safety data. Maintain up-to-date knowledge of regulatory guidelines (e.g., FDA, MDR, ISO 14971) relevant to post-market safety and vigilance. Contribute t...