55 Eu Mdr Jobs - Page 2

Experienced QA person managing multiple projects involving implementation. Ensuring set norms & laws are met. Excellent knowledge of QA processes of risk management, clinical data management, electronic data management.

#hiring for a Leadership role in #RegulatoryAffairs with reputed organization into Hi-end Medical Devices industry. Job Title: Director /VP (Regulatory Affairs) Location: Gurgaon Reports To: CEO About the Role We are seeking a highly skilled Regulatory Affairs Specialist to support global regulatory activities for our advanced Medical Devices/Equipments . This role plays a key part in developing regulatory strategies, managing submissions, and ensuring ongoing compliance for Class II and III medical devices. The successful candidate will have experience working with global health authorities, especially the US FDA , and a deep understanding of the regulatory landscape for complex medical tec...

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...

As a Lead QMS at Ai Health Highway, you will play a crucial role in implementing Quality Management System (QMS), ISO13485, EU MDR, and US FDA (510k) Risk Management processes for our cutting-edge medical devices. Your responsibilities will include creating device master records, updating technical documentation, and collaborating with internal and external stakeholders to establish a robust quality management and regulatory framework for our product pipeline. You will work closely with engineering and manufacturing teams to develop verification test strategies to ensure the safety and reliability of our products. Additionally, you will be involved in developing product requirements, support...

About OptraSCAN: We are a fast-growing health-tech company focused on building AI-enabled digital pathology solutions that are used by hospitals, laboratories, CROs, and pharma companies in over 30 countries. Our mission is to make precision diagnostics more accessible, efficient, and intelligent. With OptraSCAN , transitioning from conventional microscopy to digital pathology becomes seamless. Our solutions enable effective acquisition of whole slide images, along with features such as viewing, storing, archiving, real-time sharing, and reporting. We offer various pricing models to suit your specific needs and budget. Job Description: OptraSCAN is seeking a highly detail-oriented and knowle...

Summary Independent Project work less complexity, e.g. early phase projects. Lead or support smaller and less complex projects or support more complex projects with mentoring. Higher complex routine tasks e.g. failure investigations and deviation, change controls etc. Manage projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards. Ensure that compliance with cGMP is maintained in TRD. About The Role Key Responsibilities Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility Write review, decide on ...

Role & Responsibilities: Develop and author clinical evaluation deliverables such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) plans/reports, Post-Market Clinical Follow-up (PMCF) plans/reports, and Summary of Safety and Clinical Performance (SSCP) reports, in strict compliance with EU MDR 2017/745 and relevant global regulatory standards. Critically evaluate and synthesize clinical evidence from various sources including clinical investigations, scientific literature, PMS/PMCF data, and registries. This includes reviewing medical literature, analysing clinical risks, and providing comprehensive benefit-risk assessments for medical dev...

PMS Specialist Experience - 2-8 Years Location - Bangalore Key skills - PMS , EU MDR , Complaint Handling

Position: Production Head Experience: 10 To 20 Yrs Location: Bangalore Department: Manufacturing Industry: Medical Devices / Healthcare Technology Role Summary We are looking for an experienced and strategic Production Head to lead our manufacturing operations in the medical device domain. The ideal candidate will have deep knowledge of regulated production environments, strong people management skills, and a passion for driving quality, safety, and efficiency. This role is critical to ensuring that our products meet global standards and are delivered on time and within budget. Key Responsibilities Lead and oversee all daily manufacturing activities, ensuring production targets, timelines, a...

The candidate should be M.Sc. (Preferably Microbiology) / M.Pharm/Quality Assurance) with at least 10 /12 years of relevant experience in medical devices industry. IPQA, QMS, Validation, compliance , QA related to its processes and strategy.

Job Title: QARA ENGINEER Experience: 4.5 to 10 years Location: Bangalore Mandatory Skill: US FDA, 510K, PMA, EU MDR, QARA. Regulatory gap assessment and remediation. Job Description: The objective of this project is to identify and remediate any deficiencies in the design history files (DHF) and device master records (DMR) of the stent graft integrated with 4 branched vascular prosthesis - FROZENIX 4 Branched, ensuring adherence to relevant standards, US Food and Drug Administration ("FDA") guidelines and regulations requirements by completing all necessary tasks including document translation (Japanese to English), gap assessment, remediation and submission query support. Design verificatio...

PMS Plan/Report, PSUR (EU MDR), Complaint & Trend Analysis, Risk Assessment, Data Issue Resolution. EU MDR, ISO 14971, Complaint Trending, Risk Analysis, GDP, ISO 9001/13485, FDA 21 CFR 820/822, Cross-functional Coordination, Strong Organization.

Looking for candidates with 2–4 years of strong PMS experience in the medical device domain (preferably ortho/trauma). Must be skilled in EU MDR, PSUR, trend reports, risk assessment (ISO 14971), and complaint handling. Required Candidate profile Note: This role is exclusively for PMS professionals with hands-on experience in medical devices.

Role & Responsibilities Lead and support a team of globally located Product Assessors Conduct in-depth technical documentation reviews for Active Medical Devices Ensure compliance with EU medical device regulations and standards Collaborate with cross-functional teams to improve efficiency and service quality Monitor team performance, technical skills, KPIs, and wellbeing Handle recruitment, including CV review, interviews, and onboarding Develop and deliver technical training sessions internally and externally Provide expert support on technical and sales-related queries in Active Medical Devices Ensure top-tier service delivery within the SGS medical device certification network Preferred ...

Proficient in EU MDR, ISO 14971 Risk Management, complaint trending, and GDP. Skilled in ISO 9001, ISO 13485, FDA 21 CFR 820/822. Strong team player with ability to prioritize, self-motivate, and ensure regulatory compliance

Prepare, review, file, and support premarket documents for global registrations for assigned projects. .Review pre-clinical, and clinical protocols and associated reports to be used. Collaborate with business unit and international regulatory affairs

Knowledge and Skills Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System.

Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness ...

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team f...

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...

Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.) Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you! Minimum Qualifications Knowledge of medical regulations ...

Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.) Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you! Minimum Qualifications Knowledge of medical regulations ...

Why join AliveCor ? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that ...

Key Responsibilities: Requirements gathering and regulatory analysis Support with staffing strategy, screening, and interviews Required Expertise: Hands-on experience with ISO 13485 QMS , CDSCO dossiers , and/or FDA/CE submissions Familiarity with ISO 14971 , IEC 60601 , IEC 62304 , Indian MDR 2017 , EU MDR , and FDA 510(k) processes Strong grasp of technical documents: specs, schematics, test protocols, engineering terminology Excellent documentation, analytical, and communication skills Ability to work independently in a fast-paced, startup-like environment

Prepare and submit regulatory documentation for new and existing products. Monitor and interpret global regulatory requirements relevant to physiotherapy and medical equipment. Maintain regulatory compliance throughout the product lifecycle. Interface with regulatory agencies, notified bodies and external consultants. Ensure accurate and timely product registrations in target markets. Maintain up-to-date Device Master Files (DMF) and Technical Documentation. Support clinical evaluation and risk assessment documentation where required. Ensure products comply with applicable regulations, standards and guidelines Manage change notifications, renewals, amendments and post-market surveillance req...