36 Eu Mdr Jobs

Key Deliverables : Plan and conduct audits in compliance with ISO 13485, EU MDR, and MDSAP standards. Review and evaluate technical files and documentation for medical devices. Collaborate with audit teams to ensure quality, compliance, and client satisfaction. Support certification decisions and regulatory reviews as per DNV and accreditation guidelines. Role Responsibilities : Execute audits independently and manage auditing teams when needed. Maintain audit documentation and timely delivery of reports. Ensure adherence to global regulatory and accreditation standards. Engage with clients and internal stakeholders to support quality assurance.

We are seeking an experienced Supplier Quality Professional Trainer with 10+ years of expertise in managing supplier quality assurance , supplier development, and compliance in regulated industries (pharmaceutical, biotech, or medical devices). The role involves ensuring suppliers meet company , industry, and regulatory standards by leading audits, driving quality improvement initiatives , and building strong supplier partnerships. Job Responsibilities: Develop and manage supplier quality strategies, policies, and risk management processes. Lead supplier qualification, selection, and approval in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP). Conduct supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements. Oversee supplier corrective and preventive actions (CAPA) , root cause analysis, and continuous improvement programs. Collaborate with cross-functional teams (procurement, R&D, operations, quality) to resolve supplier-related issues. Monitor supplier KPIs (on-time delivery, defect rates, deviations, complaints) and drive improvement initiatives. Support new product development (NPD) by ensuring supplier capability for components, raw materials, and services. Manage supplier change control processes and evaluate impact on product quality and regulatory compliance. Train, mentor, and guide internal teams and suppliers on quality systems and compliance expectations. Ensure alignment with global regulatory requirements (FDA 21 CFR Part 11/210/211, ISO standards, EU MDR, ICH guidelines). Core Competencies & Skills Strong expertise in supplier quality management, auditing, and regulatory compliance . In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, IATF 16949 (if automotive/industrial) . Proficiency in risk management, root cause analysis, CAPA, Six Sigma, Lean methodologies . Excellent communication, negotiation, and stakeholder management skills. Ability to lead supplier development programs and strategic quality initiatives. Experience in global supplier management and multicultural environments. Qualifications: Bachelor's/Master's degree in Engineering, Life Sciences, or related field. 10+ years of experience in supplier quality assurance, preferably in pharma/medical devices/regulated manufacturing industries. Certified Lead Auditor (ISO 9001/13485, GMP, or equivalent) preferred. Six Sigma Green/Black Belt certification is a plus. Proven track record in managing global suppliers and delivering measurable quality improvements.

You will be joining Kaushik Orthopaedic as a Senior Product Development Engineer, specializing in New Product Development. With our headquarters in Delhi-NCR and a strong global presence across markets in EMEA, South East Asia, and Latin America, we have been a leading Orthopaedic Device Manufacturer since 1989. As a qualified candidate, you should hold a Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field. You must have a minimum of 5+ years of experience in designing and developing medical devices, particularly orthopaedic implants and instruments. Your expertise should encompass design principles, biomechanics, and materials science. Proficiency in CAD software such as AutoCAD, SolidWorks, and Creo, as well as simulation tools like FEA and CFD, is essential. Moreover, a comprehensive understanding of Regulatory Compliance requirements like US FDA 510k, EU MDR, Indian FDA, Brazil ANVISA, etc., is necessary for this role. Your primary responsibilities will include taking complete ownership of the New Product Development initiatives at Kaushik Orthopaedic. You will collaborate closely with cross-functional teams, including R&D, manufacturing, and quality assurance. Your tasks will involve developing and managing design documentation, comprising DHFs, CAD models, drawings, and specifications. Additionally, you will be responsible for conducting feasibility studies, prototyping, and testing new designs, as well as supervising the Design and Development Engineering Team. The compensation for this role is competitive and negotiable, reflecting your skills and experience. The position is based in the Rai Industrial Area, Sonipat, Haryana, offering you a dynamic work environment in a strategic location.,

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Job Description We are looking for a skilled & driven Product Owner with a strong technical background and experience in the healthcare domain. The ideal candidate will lead the product /platform development efforts, ensuring seamless integration with LIS, EMR, and EHR systems, and compliance with healthcare regulations like HIPAA and GDPR. This role requires expertise in agile product management, backlog prioritization, and healthcare interoperability standards such as HL7, FHIR, and DICOM. The Product Owner will serve as the bridge between technical teams, stakeholders, and end users to deliver impactful, innovative, and compliant healthcare solutions. Roles & Responsibilities Collaborate with stakeholders & technical product managers to define and execute the product vision, strategy, and roadmap. Define and prioritize the product backlog, ensuring alignment with business objectives and customer needs. Write clear, detailed user stories and define acceptance criteria for successful implementation. Work closely with cross functional stakeholders including regulatory & engineering teams - Development, QAs & DevOps to ensure technical feasibility and timely delivery of features. Ensure compliance with healthcare standards and regulations, including HIPAA and GDPR. Drive end-to-end integration with LIS, EMR, and EHR systems, ensuring interoperability through standards like HL7, FHIR, and DICOM. Leverage domain knowledge to address challenges in healthcare workflow automation, data sharing, and interoperability. Facilitate agile ceremonies, including sprint planning, daily stand-ups, retrospectives, and PI planning. Act as the technical and functional subject matter expert for healthcare-related integration requirements. Lead SaMD-specific documentation: product requirements, risk assessments, validation records, user manuals, and regulatory submissions. Define and own the SaMD product roadmap, aligning with business goals, regulatory standards (e.g., ISO 13485, IEC 62304), and user needs. Ensure risk management and compliance through standards-based hazard analysis, cybersecurity evaluation, and regulatory alignment (e.g., FDA/EU MDR or GxP) Engage external vendors or legal manufacturers, aligning deliverables with internal standards and regulatory expectations. Qualifications: Bachelor's/Master's degree in Engineering (Computer Science/IT) with 8+ years of experience in building healthcare related software products. Proven experience as a Product Owner in the healthcare domain - especially around SaMD - Software as-a Medical Device, & with LIS, EMR, and EHR integrations. Good technical expertise, with familiarity in APIs, data security, and interoperability standards (HL7, FHIR, DICOM). SAFe Product Owners/Product Manager Certification, Certified Scrum Product Owner (CSPO) or similar agile certification. Hands-on experience in working with teams using SAFe. Excellent skills in writing user stories, defining acceptance criteria, and managing product backlogs. Ability to work effectively with cross-functional teams in an agile environment. (Business, Architects, POs, Devs, QAs and Executive leaderships) Strong problem-solving abilities and attention to detail in a fast-paced development lifecycle. Exceptional interpersonal and communication skills, with the ability to bridge gaps between technical and non-technical stakeholders. Good understanding of healthcare compliance and data privacy regulations (e.g., HIPAA, GDPR). Why Join the AlgoSuite team at Roche Our team is building the next generation platform called navify AlgoSuite , which makes the high medical value algorithms accessible to the hospitals, labs and healthcare professionals and in-turn helping large numbers of patients across the world. That is why we come to work every single day and commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Who we are A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an Equal Opportunity Employer.

Position Title: Regulatory Affairs & QA Manager Department: Quality & Regulatory Affairs Location: Bangalore Role Overview The Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485, MDR, US FDA, and other relevant standards. This role is critical in bridging product development, regulatory submissions, audits, and market access, ensuring patient safety and product quality at all times. Key Responsibilities Regulatory Affairs: Develop and implement regulatory strategies for product registration, approvals, and certifications (CE marking, US FDA, CDSCO, etc.). Prepare, compile, and submit regulatory dossiers for global markets. Act as liaison with regulatory authorities, notified bodies, and certification agencies. Monitor changes in global regulatory requirements and assess impact on company products. Support product labeling, claims, and advertising compliance with regulations. Maintain regulatory databases, technical files, and Design Dossiers. Quality Assurance: Lead and maintain the companys Quality Management System (QMS) in line with ISO 13485, ISO 14971 (Risk Management), MDR, and FDA QSR (21 CFR Part 820) . Plan, conduct, and manage internal and external audits (regulatory, customer, notified body). Ensure effective CAPA (Corrective and Preventive Action) and complaint handling processes. Oversee supplier qualification, incoming inspection, and vendor audits. Ensure proper document control, change control, and training compliance. Drive continuous improvement in quality systems, manufacturing processes, and compliance culture. Cross-functional Support: Work closely with R&D and Manufacturing for design control, risk assessment, and regulatory compliance during product development. Support clinical evaluation, PMS (Post-Market Surveillance), and vigilance reporting. Provide training and regulatory/quality guidance to internal teams. Key Requirements Education: Bachelors / Masters degree Experience: Minimum 610 years in Regulatory Affairs and Quality Assurance in the medical device industry . Strong knowledge of ISO 13485, MDR 2017/745, IVDR, US FDA 21 CFR Part 820, ISO 14971, IEC 60601, and other relevant standards . Proven experience in regulatory submissions, audits, and product registrations . Excellent understanding of QMS implementation and maintenance . Strong analytical, documentation, and project management skills. Effective communication and leadership skills to work with cross-functional teams and external regulators. Kindly fill the below mentioned details Notice Period: Current Salary: Expected Salary: Current Address: Experience in USFDA: Experience in EU MdR: Experience in CDSO: Experience in Product Registration: Availability for a Google Meet interview Preferred Date: Preferred Time: Kindly share your update resume to Mithun@futura.limited or WhatsApp: 6366138846 .

Job Title Software Quality Engineer Job Description Job title: Software Quality Engineer Your role: Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design. Validates key design inputs (i.e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs). Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle. Can lead quality related problem solving for software. Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions as necessary, as required. Act as a business partner, single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards for every milestone. You're the right fit if: (4 x bullets max) 1. Experience- 10+ years of industry experience in PQE 2. Skills: Worked in medical industry product development team (exp of 3 to 8 years) as QE. SW domain is must. Strong knowledge in QMS 13485, 21 CFR, EU MDR, SW LC 62304, Usability 62366, RMM 14971 and experience in guided R&D team. Heavily involved in all design control doc reviews and maintained DHF. Guided R&D team for Defects Handling and tracked defects. Experience in handled internal & External audits Prepared QMS procedures and Templates are additional advantage. Good knowledge in CAPA, Regulatory, Verification and Post Market Surveillance. 3. Education- Candidate shall be with B Tech in Computer Science (or) experience as SW Developer 4. Anything else- Must following one the skills ISO 13485 - Quality management systems for Medical Devices IEC 62304 - Medical device software - Software life cycle processes ISO 14971 - Application of risk management to medical devices IEC 82304 - Health software, Product Safety IEC 62366-1 - Application of usability engineering to medical devices EUMDR - European Medical Device Regulation 21CFR - US FDA Medical Regulation How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. . Learn more about . . Discover . . Learn more about . If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

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 technologies. Key Responsibilities:- Regulatory Strategy s Compliance Develop and execute global regulatory strategies aligned with product development and commercialization goals. Provide regulatory input across the product lifecycle, from development through post-market activities. Monitor, interpret, and communicate changes in global regulatory requirements (FDA, EU MDR, ISO 13485, MDSAP). Act as the point of contact with regulatory bodies and support agency interactions, including Q-subs and audits. Ensure compliance with global regulations, labelling standards, and post-market reporting obligations. Submissionss Approvals Prepare and manage regulatory submissions including FDA Q-submissions, IDEs and related. Support regulatory filings and approvals in the U.S., EU, and other international markets. Oversee clinical documentation and data integration into marketing applications. Ensure submission accuracy, completeness, and adherence to timelines. Cross-functional Collaboration Lead and collaborate with cross-functional teams including RCD, Quality, Clinical, and Marketing. Coordinate submission activities to ensure high-quality, on-time deliverables. Manage regulatory project plans, risk assessments, and progress reports. Provide guidance and mentorship to junior regulatory staff or project contributors. Qualifications:- Bachelor's or masters degree in Life Sciences, Engineering, Regulatory Science, or related field. Prior experience with a regulatory agency (e.g., US FDA) preferred. Minimum 10+ years of experience in Regulatory Affairs, including leadership in global regulatory projects. In-depth knowledge of FDA regulations , EU MDR/MDD , MDSAP , and ISO 13485 . Proven success with regulatory submissions for Class II and III medical devices . Strong project management, communication, and organizational skills. Preferred Skills Experience working in a regulated medical device environment involving . Ability to interpret complex regulatory guidelines and apply them in a practical business context. Demonstrated leadership in global regulatory project execution. What We Offer Global exposure and professional growth opportunities Competitive compensation and benefits Opportunity to work with cutting-edge medical technologies A collaborative, innovation-driven environment If Interested, kindly share CV to: recruit.corp12@apexservices.in

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 surveillance for software updates. Support validation and verification activities, including unit testing, integration testing, and system testing under regulatory frameworks. Deep understanding of IEC 62304, ISO 14971, ISO 13485, IEC 82304 guidelines, and Usability and FDA (Pre- and Post-market) Cybersecurity Guidelines. Prior experience with FDA 510(k) or PMA/De-Nova submissions and regulatory submissions. Maintaining a complete track record of all the software changes and documents. Education Bachelors or masters degree in software engineering, Computer Science, Biomedical Engineering, or related field. Experience: Minimum 25 years of experience in medical device software QA/RA. Hands-on experience with regulatory submissions (FDA, EU MDR).

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, supporting validation programs for new product development, and providing inputs for regulatory guidelines and procedures. Your expertise in risk assessment for medical devices, as per ISO13485/ISO 14971 CE certification, will be essential in this role. You will also be responsible for reviewing device labelling and advertising materials for compliance with regulations, liaising with external consultants, and assisting in documentation preparation for US FDA (510k) and EU-CE Marking regulatory submissions. To be successful in this position, you should have 3 to 5 years of experience in the Medical Device QMS and regulatory domain, along with a BTech/BE in Electronics/Electrical/CS or Bio-Medical Engineering. Strong skills in documentation, review, reporting, and excellent interpersonal communication are required. Experience in managing non-conformance, corrective action preventive actions, deviation, and conducting QMS training will be beneficial. Join us at Ai Health Highway in our mission to reduce premature deaths due to Non-Communicable Diseases by 30% by 2030. Your expertise and dedication will contribute significantly to our goal of revolutionizing healthcare with innovative medical devices.,

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 knowledgeable Regulatory Specialist Technical Writer to create, manage, and maintain regulatory documentation required for product approvals, certifications, and market access in global markets. This role involves a combination of regulatory strategy and high-quality technical writing for medical devices (hardware and software), with a focus on ensuring compliance with international standards such as ISO 13485, FDA 21 CFR Part 820, EU MDR, and others. Note: - Apply only if you have experience in IEC 62304 ,IEC 62366, IEC 60601, ISO 14971. Key Responsibilities: Regulatory Documentation & Submissions. Prepare and maintain high-quality regulatory documentation including: Technical Files / Design Dossiers Clinical Evaluation Reports (CERs) Risk Management Files Declarations of Conformity FDA submissions (510(k) or pre-submissions, if applicable) Collaborate with cross-functional teams to gather inputs from R&D, QA, Clinical, and Marketing for submission documents. Technical Writing: Write, edit, and proofread SOPs, work instructions, user manuals, labeling, and IFUs to ensure technical accuracy and regulatory compliance. Translate complex technical data into clear, concise, and user-friendly documentation. Compliance & Standards: Stay current with regulatory changes (EU MDR, FDA, etc.) and update internal documentation and processes accordingly. Ensure documentation aligns with applicable standards such as: ISO 13485 ISO 14971 (Risk Management) IEC 62304 (Software Lifecycle) IEC 62366 IEC 60601 (Electrical Medical Devices) EU MDR 2017/745 FDA 21 CFR Part 820 Quality System Support: Support internal audits and inspections by maintaining complete and audit-ready documentation. Assist in CAPA documentation and post-market surveillance reports when required. Required Qualifications: Bachelors or masters degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. 25 years of experience in regulatory writing or regulatory affairs in a medical device or healthcare product environment. Strong knowledge of global medical device regulatory frameworks (FDA, EU MDR, etc.). Excellent written English and technical writing skills. Strong organizational and project management skills. Preferred Qualifications: Experience preparing 510(k), CE Mark, or similar submissions. Familiarity with digital pathology, imaging devices, or software as a medical device (SaMD). Certification in Regulatory Affairs (e.g., RAPS RAC) is a plus. Show more Show less

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 approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables. Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility. Support Project management functions as a project team member. Provide support to TRD line functions in GMP related topics as per area of responsibility. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.). Manage a Design History File / Tech File portfolio of assigned Medical Device/ Drug Device Combination projects from Quality perspective and provide functional expertise in responsibility for medical devices and combination products in cross-functional project teams to assure cGMP Compliance with medical device specific regulations (ISO 13485:2016, EU MDR, 21 CFR 820 and 21 CFR Part 4) and internal Novartis standards for Medical Device development products under submission and Life Cycle Management activities. He/She ensures the quality specific tasks of a Design History File and follow-up including supporting medical device reporting to regulatory authorities. Monitoring, analysis, and reporting of GMP related KPIs as part of management reporting, Review QA agreements for Medical Device projects. Coordinate complaint investigations for Medical Device projects. Review of release documentation for medical device components. Support PMS activities for Medical Device projects. Support QMS and Audit (external and internal) activities Minimum Requirements Masters, Bachelor/Technician (> 5 years pharma) Fluent English required (oral & written) Good skills in site (local) language desired. Good knowledge of cGMP, working knowledge in technical development, production or QA. Sound scientific, technical and regulatory knowledge. Good organizational and decision-making skills. Good and proven ability to analyze and evaluate cGMP compliance. Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [HIDDEN TEXT] and let us know the nature of your request and your contact information. Please include the job requisition number in your message Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

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 devices. Collaborate cross-functionally with teams in Regulatory Affairs, R&D, Quality Assurance, Sales, and Marketing to ensure alignment on clinical evaluation project deliverables and support product development, approval, and post-market activities. Review and provide feedback on Instructions for Use (IFUs), patient guides, clinical study protocols, and clinical investigation reports to ensure consistency and compliance with regulatory requirements. Manage responses to regulatory authorities (e.g., Notified Bodies and Competent Authorities), addressing complex queries related to clinical evaluations and ensuring compliance with EU MDR and other regulatory frameworks. Ensure quality and integrity of documentation, maintaining attention to detail, consistency, and adherence to regulations such as ISO 13485, ISO 14155, MEDDEV 2.7/1 Rev 4, and EU MDR 2017/745. Support regulatory submissions by providing clinical evidence for product approvals, indication expansions, and ensuring compliance with post-market surveillance and clinical follow-up obligations. Stay current with global regulations and standards, including MDR, MEDDEV, and ISO, and effectively communicate the implications of evolving regulatory landscapes to internal stakeholders. Requirements: Advanced degree in life sciences, biomedical engineering, or a related medical/scientific discipline. 4 to 5 years of experience in clinical evaluation, medical writing, or a related role in the medical device industry, with a focus on clinical evaluation documentation Proven experience in medical writing, with a strong focus on clinical evaluation documentation for medical devices. In-depth knowledge of EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, and relevant ISO standards (ISO 13485, ISO 14155). Excellent ability to critically appraise clinical data and present well-organized, scientifically sound reports. Strong technical and medical writing skills, with an ability to convey complex information clearly and concisely. Experience with regulatory submissions and addressing Notified Body/Competent Authority queries is a plus.

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, and quality standards are met. Develop and implement effective production strategies aligned with company goals. Ensure full compliance with regulatory and quality standards, including ISO 13485, FDA21 CFR Part 820, and EU MDR. Manage cleanroom operations and ensure adherence to safety and hygiene protocols. Plan and optimize resource allocation including manpower, materials, and machines. Implement and promote Lean Manufacturing, 5S, Six Sigma, and other process improvement techniques. Coordinate with cross-functional teams such as Quality, R&D, Regulatory Affairs, SCM, and Maintenance. Oversee preventive and corrective maintenance of production equipment and ensure minimal downtime. Ensure documentation practices meet Good Manufacturing Practices (GMP), including DMR, DHR, CAPA, NCR, etc. Train, mentor, and lead the production team to drive productivity and accountability. Participate in internal, external, and regulatory audits. Qualifications Bachelors/Masters degree in Mechanical / Industrial / Biomedical Engineering or related field. Certifications in Lean, Six Sigma (Green/Black Belt), or ISO 13485 are an advantage. Experience 12-20 years of experience in manufacturing, with at least 5 years in the medical device or pharma industry. Prior leadership role in managing large-scale, regulated production lines. Key Competencies In-depth knowledge of regulatory standards (ISO 13485, GMP, FDA, EU MDR). Excellent team leadership, communication, and conflict-resolution skills. Proven track record in implementing continuous improvement and cost-saving initiatives. Hands-on experience with ERP/MES systems. Strong analytical and decision-making abilities. Why Join Us? Opportunity to lead in a fast-growing, innovation-driven organization Work on cutting-edge medical technologies that impact lives A culture that values quality, teamwork, and continuous learning

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 verification and Validation US FDA 510k submission process US FDA Premarket approval ISO 14971 - Medical device risk management DHF Gap assessment DMR Gap assessment EU MDR 2017/745 regulations CE Technical documentation Technical standards and guidance (for medical device) ISO 60601 Electrical safety IEC 62304 - Human factors and Usability engineering ISO 10993 - Biocompatibility testing

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 Candidate Profile Strong experience in Active Medical Devices or regulatory affairs Proven leadership and mentoring abilities Excellent communication and cross-functional collaboration skills Familiarity with EU MDR and quality compliance processes Experience in technical assessments and certification services

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 of the QMS and identify areas for improvement. 4. Lead corrective action and continuous improvement initiatives to address quality issues and improve processes. 5. Develop and maintain quality-related documentation, including procedures, work instructions, and records. 6. Provide training and support to employees on QMS policies, procedures, and requirements. 7. Manage and analyse quality data, including customer complaints, internal rejects, and supplier performance. 8. Collaborate with cross-functional teams, including production, engineering, and procurement, to ensure quality requirements are met. 9. Maintain relationships with external parties, including customers, suppliers, and certification bodies. 10. Stay up-to-date with changes in regulations, standards, and industry best practices. # Requirements: 1. Bachelor's degree in a relevant field (e.g., QMS/BE/MBA). 2. Minimum 8 -10 years of experience in a QMS role, preferably in the plastic molding industry. 3. Certification in a recognized quality management standard (e.g., ISO 9001, IATF 16949). 4. Strong knowledge of quality management principles, including lean manufacturing, Six Sigma, and continuous improvement. 5. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 6. Strong analytical and problem-solving skills, with the ability to interpret data and make informed decisions. 7. Proficient in Microsoft Office and quality management software. # Nice to Have: 1. Experience with industry-specific regulations and standards (e.g., FDA, EU MDR). 2. Certification in a related field (e.g., quality engineering, supply chain management). 3. 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 of the QMS and identify areas for improvement. 4. Lead corrective action and continuous improvement initiatives to address quality issues and improve processes. 5. Develop and maintain quality-related documentation, including procedures, work instructions, and records. 6. Provide training and support to employees on QMS policies, procedures, and requirements. 7. Manage and analyse quality data, including customer complaints, internal rejects, and supplier performance. 8. Collaborate with cross-functional teams, including production, engineering, and procurement, to ensure quality requirements are met. 9. Maintain relationships with external parties, including customers, suppliers, and certification bodies. 10. Stay up-to-date with changes in regulations, standards, and industry best practices. # Requirements: 1. Bachelor's degree in a relevant field (e.g., QMS/BE/MBA). 2. Minimum 8 -10 years of experience in a QMS role, preferably in the plastic molding industry. 3. Certification in a recognized quality management standard (e.g., ISO 9001, IATF 16949). 4. Strong knowledge of quality management principles, including lean manufacturing, Six Sigma, and continuous improvement. 5. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 6. Strong analytical and problem-solving skills, with the ability to interpret data and make informed decisions. 7. Proficient in Microsoft Office and quality management software. # Nice to Have: 1. E xperience with industry-specific regulations and standards (e.g., FDA, EU MDR). 2. Certification in a related field (e.g., quality engineering, supply chain management). 3. Experience with quality management software (e.g., QMS, EQMS)

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 for internal / external audit compliance for ISO and CE marking Responsible for surveillance of regulatory guidance/ standards applicable to medical devices in the respective geographies in which Cipla products are distributed. Key Accountabilities: Develop, establish and maintain the QMS for medical devices according to EU MDR and ISO 13485 requirements. Surveillance of new/updated regulatory guidance/ ISO standards applicable to medical devices as per Ciplas product portfolio to ensure compliance to latest regulations. Surveillance of EU noncompliance reports / CDSCO / USFDA etc that are applicable to medical devices manufactured by Cipla to enable continuous improvement. Execution of Quality Management Review meeting for Medical devices and implementation of actions derived in the QMR meetings. Conduct audit of Vendors / contract manufacturers/ outsourced activities associated with medical device manufacturing/ servicing/ testing/ distribution. Ensure timely submission of quality documents to fulfil regulatory requirements. Major Activities / Tasks: Develop and establish Management responsibility system as per ISO 13485 and EU MDR Develop and establish design control system for EU market. Develop and establish key performance indicators (KPIs) for monitoring site performance and effectiveness of QMS as per ISO 13485. Prepare SOPs, Quality manual etc.as per ISO 13485/ EU MDR. Responsible to maintain compliance to ISO 13485 by adhering to SOPs and ensuring control and oversight over adherence by respective depts to SOPs. Periodic review of SOPs related to medical devices as per regulatory requirements and update. Arrange training and promote awareness among cross functional teams on ISO 13485 QMS and CE Marking Ensure readiness from QMS standpoint for internal and external audits. Provide guidance and support during internal and external audits examining compliance to EU MDR/ISO 13485 requirements. Co-ordinate with cross functional teams for internal/ external audit compliance. Create library of ISO standards. Review new/upcoming/ draft/ revised/ final regulatory guidance/ ISO standards related to medical devices applicable as per Ciplas product portfolio. Gap assessment of the guidance / standards in comparison to QMS at Cipla and identify suitable actions prior to implementation of the guidance/standard. Monitor implementation of the actions to enable continuous improvement. Schedule quality management review (QMR) meeting for medical devices. Collate data required for the QMR and prepare the presentation on site performance to monitor effectiveness of Quality management system. Appraise management representative regarding critical issues. Monitor implementation of the action plans derived from QMR by coordinating with other cross functional team. Audit of Vendors supplying Medical devices and Invitro diagnostic kits, completing audit documentation and verifying actions taken by the audited site to correct non-conformances observed. Audit of CMOs manufacturing medical devices, completing audit documentation, and verifying actions taken by the audited site to correct non-conformances observed. Audit of outsourced activities related to medical devices manufacturing/ servicing/ testing/ distribution. Coordinate with RA, QA team and Pharmaco vigilance team through emails and phone to enable timely submission of the documents. Major Challenges: Establishing Quality Management System for Medical devices according to EU MDR / ISO 13485 is new for Cipla, hence developing and maintaining it will be a challenge. Cross functional support is key in ensuring adherence to QMS, as challenge is awareness about EU/ ISO 13485 certification requirements is low in cross functional teams such as IPD/ RA/ SCM/FPS/ DSD, Marketing. Same can be overcome by promoting awareness about EU MDR/ISO 13485 requirements at the outset/ from time to time. Engage in Notified bodies audits for ISO and CE marking audits and coordinate with all Cipla teams for audit management. Coordinate with Cipla team for audit compliance. Skills & Knowledge: Educational qualifications: MSc./ MPharm/ if MTech then in Biomedical engineering; Certificate courses/diploma in ISO audits highly welcome Relevant experience: At least 9-10 years of experience in Quality of Medical Devices/IVDs /Implants Experience in regulated market product approvals e.g. US FDA is a high plus