906 Mdr Jobs - Page 9

The Production Lead will oversee end-to-end manufacturing operations for active medical devices, ensuring smooth, efficient, and cost-effective production while maintaining compliance with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and GMP requirements. While regulatory submissions are handled separately, this role ensures production-level compliance, process validation, and continuous improvement in the shop floor environment. Key Responsibilities Production Management Plan and execute daily/weekly/monthly production schedules aligned with demand forecasts. Manage assembly, integration, and testing of active medical devices to meet quality and delivery commitments. Ensure cleanroom ...

Role: L2 SOC Location: Hyderabad Shift Timings: Rotational about alliantgroup alliantgroup is a professional services firm that provides tax consulting and compliance services to businesses in the United States. The company was founded in 2002 and is headquartered in Houston, Texas. alliantgroup services are focused on helping businesses claim tax credits and incentives that they are entitled to under various federal and state programs. These credits and incentives are designed to encourage businesses to invest in certain types of activities, such as research and development, energy efficiency, and hiring employees from certain disadvantaged groups. alliantgroup services include helping busi...

Job Title Post Market Surveillance (PMS) Specialist Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own an...

Job Title Post Market Surveillance (PMS) Specialist Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own an...

Job Title Post Market Surveillance (PMS) Specialist Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own an...

Job Summary Senior Delivery Manager role in the R&D Software Division of a global leader in hearing aid technology. Critical leadership position responsible for end-to-end delivery of consumer-facing mobile applications and web portals. Ensure seamless collaboration across diverse internal teams while aligning with product strategy and business goals. Ideal candidate should bring strong technical understanding, delivery excellence, stakeholder engagement, and team leadership. Experience in healthcare, pharma, or medical device domains is highly preferred. Key Responsibilities Lead and manage multiple high-performance agile teams to deliver high-quality software solutions. Plan and execute th...

Company Description About Sopra Steria Sopra Steria, a major Tech player in Europe with 50,000 employees in nearly 30 countries, is recognised for its consulting, digital services and solutions. It helps its clients drive their digital transformation and obtain tangible and sustainable benefits. The Group provides end-to-end solutions to make large companies and organisations more competitive by combining in-depth knowledge of a wide range of business sectors and innovative technologies with a collaborative approach. Sopra Steria places people at the heart of everything it does and is committed to putting digital to work for its clients in order to build a positive future for all. In 2024, t...

Job Title System Test and Verification Engineer - Automation Job Description Job title: Test and Verification Engineer Be part of a multidisciplinary team of highly skilled technical specialists working on innovative (automated) test solution projects. These projects can cover every phase of the product life cycle, from development, manufacturing (manufacturing test development, fitness for use, MSA’s) and maintenance. In your role, you will work with together with Test architects, the SW architects (automation) and other T&V Engineers from within our own organization as well as from our customers organization. You are responsible for Software Development for ATE(Automated Test Equipment), t...

Youll make a difference by: Being responsible for the software architecture, design and development related to Siemens SINAMICS Drive software portfolio and supports the software to advance the product portfolio Developing a complex drive engineering application on Windows in a multithreaded environment Planning, performing and supervising software architecture activities within the project / project modules adhering to timeline, quality and features. Having technical discussions with project partners and conducting functional analysis of existing software Deriving software requirements and software functional specification, validate software requirements, provide software feasibility analys...

Summary The Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy. They provide expert support ensuring the development, implementation and timely availability of consistent, high quality Clinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries including; Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer...

Associate Detection & Response Analyst - MDR We are seeking someone with a passion for cyber security to join our team. As a SOC Analyst with Rapid7 you will work with Rapid7’s advanced tools to investigate and triage high priority security events. Working with Rapid7’s Tactical Operations team (TACOPS) is an ideal opportunity to gain a deep understanding of threat detection and response. As part of this team you will be in the best position to develop the skills needed to build a career in cyber security. This is a hybrid role based in our Arlington, VA Security Operation Center. About The Team Rapid7 Managed Detection and Response (MDR) is built from the ground up to bring motivated and pa...

Company Description About Sopra Steria Sopra Steria, a major Tech player in Europe with 50,000 employees in nearly 30 countries, is recognised for its consulting, digital services and solutions. It helps its clients drive their digital transformation and obtain tangible and sustainable benefits. The Group provides end-to-end solutions to make large companies and organisations more competitive by combining in-depth knowledge of a wide range of business sectors and innovative technologies with a collaborative approach. Sopra Steria places people at the heart of everything it does and is committed to putting digital to work for its clients in order to build a positive future for all. In 2024, t...

Project Manager is responsible for overseeing and executing complex projects within a regulated medical device environment. This role is essential for ensuring project delivery in accordance with established timelines, defined scope, and allocated budgets, while maintaining strict adherence to regulatory requirements and industry standards. The Project Manager will lead strategic initiatives, promote continuous improvement, and support the organization's success and innovation objectives. Success in this role requires outstanding leadership abilities, strategic acumen, and the capacity to effectively manage multiple projects in a dynamic, fast-paced setting. Main tasks :Lead and manage proje...

Key Responsibilities: Model Development & Optimization Design and implement AI/ML models for online spectacles centration, fitting and online refraction. Develop models for online visual acuity assessment, screen-based testing, or optical prescription estimation. Develop models that replaces and enhances online measurement approaches through innovative data and AI-supported methods. With the midterm goal: Data replaces measurement. Implement and launch AI based solutions, fulfilling regulatory and legal requirements. Data Handling & Preprocessing Work with multi-modal datasets Ensure that necessary data is gathered accurately and efficiently. Annotate, normalize, and augment vision-related d...

Role & responsibilities Job Description -Software Quality Engineer (QA/RA) Design, develop, and optimize high-performance SAMD applications using SIMD for real-time. Ensure all software development complies with regulatory standards such as IEC 62304, ISO 13485, FDA 21 CFR Part 820, and EU MDR. Collaborate with cross-functional teams (RA/QA, Software/firmware development, and R&D teams) to ensure the software meets safety and performance requirements. Create and maintain documentation such as SDLC deliverables, Risk management files, Verification and Validation protocols, Usability, and Cybersecurity deliverables. Participate in internal audits, regulatory submissions, and post-market survei...

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

Department: Quality Assurance Reporting To: QA Manager / Head – Quality Position Summary The Assistant Manager – QA (Compliance & Regulatory Affairs) will be responsible for ensuring compliance with national and international regulatory requirements applicable to medical devices, overseeing quality management system effectiveness, and maintaining certifications. The role demands strong expertise in ISO 13485 and ISO 9001 standards, regulatory submissions, and internal/external audits. Key Responsibilities · Regulatory Compliance: - Ensure compliance with Medical Device Rules (MDR 2017), BIS QCO requirements, and other applicable national/international regulations. - Prepare, review, and main...

Job description We Are Hiring Regulatory Affairs Specialist 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 Office. ...

Job Title: Regulatory Affairs Specialist Location: Okhla Phase-1, Delhi-110020 Department: Regulatory Affairs Reports To: Head of Quality & Regulatory Employment Type: Full-Time Job Summary: We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to ensure our medical devices comply with all regulatory requirements in domestic and international markets. The ideal candidate will have a strong understanding of medical device regulations (e.g., ISO 13485, MDR, US FDA 21 CFR Part 820) and a proven track record in managing regulatory submissions, documentation, and audits. Key Responsibilities: Prepare, compile, and submit regulatory documents for product approvals/regist...

The opportunity To support the execution of Projects with medium to high complexity and ensure that all related activities are executed in accordance with company procedures, contract specifications, quality standards, documentation, health, safety and environment requirements, cost/ profitability targets and scheduling targets. How You’ll Make An Impact Filing of drawings in accordance with HEAU drawing management requirements on Sharepoint; Keep the HEAU document register up to date. Submission of drawings via Client Document Management Systems (DMS) for projects as requested by the respective PM. Prepare / modify documents as required to comply with Contract DMS requirements. Liaise with ...

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and de...

The Opportunity: . The Opportunity: Ensure uninterrupted product manufacturing by executing production activities aligned with established quality and operational standards. Drive consistency and efficiency through adherence to defined procedures and responsibilities. What we are looking for: Experience: Min 05-06 years of Exp of relevant experience Educational Qualification : Postgraduate or above in Sciences – Life Science /Biotechnology Microbiology/Chemistry /Pharmacy. Manage the workforce for manufacturing of IVD products manufacture at Dehradun plant through a staff of both professionals and contract labor. Supervision of assigned work/operations of Rapid/ELISA/Biochemistry/Hematology ...

Educational Requirements Master Of Engineering,MTech,Bachelor of Engineering,BTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide y...

About Us Sophos is a global leader and innovator of advanced security solutions for defeating cyberattacks. The company acquired Secureworks in February 2025, bringing together two pioneers that have redefined the cybersecurity industry with their innovative, native AI-optimized services, technologies and products. Sophos is now the largest pure-play Managed Detection and Response (MDR) provider, supporting more than 28,000 organizations. In addition to MDR and other services, Sophos’ complete portfolio includes industry-leading endpoint, network, email, and cloud security that interoperate and adapt to defend through the Sophos Central platform. Secureworks provides the innovative, market-l...

About the Role As a Product Manager for Card Acquiring , you will be responsible for building and scaling card-based payment products for our vast network of offline and online merchants. You will work closely with banks, networks (Visa, Mastercard, Rupay, American Express), and internal teams to deliver high-performance card processing solutions. You will be the voice of the merchant and the architect of high-SR, low-latency, and regulation-compliant card payment Responsibilities:- Own the end-to-end lifecycle of card acquiring products from strategy and roadmap to execution and post-launch performance. Define product features and enhancements focused on card payment acceptance across POS, ...