1232 Mdr Jobs - Page 3

POSITION DESCRIPTION: The Quality and Regulatory Affairs (QARA) Specialist will provide leadership in the quality and regulatory affairs function to understand regulatory requirements of medical devices, create relevant documentation and providing consultancy as an expert in regulatory affairs for IZiel clients The RA specialist will work with clients in India and globally across USA and Europe to provide solutions for getting approvals for their products for launch in the Europe and USA The candidate will require to go through extensive training in various country specific regulations as needed to keep themselves up-to-date with the latest and greatest updates as well as represent IZiel at ...

IMMEDIATE JOINERS ONLY Job Title: Business Analyst Location : Mumbai, MH (WFO) Skills Required: Business Analysis Experience Range Required: 6-8 Years(Rel 5 yrs.) Job Description: 6-10 years of experience Location: 1 Onsite and 1 offshore (Preferred location in Mumbai, though we are open to all location) Requirement Elicitation and Analysis Need BA with Clinical domain knowledge (MDR preferably) Work closely with business stakeholders to understand their needs, objectives, and challenges. Elicit, document, and analyze business requirements, processes, and workflows. Translate business requirements into clear and concise functional and non- functional specifications for technical teams. Solut...

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 Conduct gap assessments of product development processes and documentation against applicable medical device standards and regulations. Evaluate compliance with: ISO 13485 (Quality Management Systems) ISO 14971 (Risk Management) IEC 62304 (Software Lifecycle) FDA 21 CFR Part 820 (Quality System Regulation) EU MDR (Medical Device Regulation), if applicable IEC 6...

Overview: JOB SUMMARY: The Quality Assurance Engineer shall provide leadership and support for QMS performance in many facets of business operations: Design Control To ensure the release of safe, effective and compliant medical devices, the Quality Assurance Engineer shall provide Quality System Design Control mentoring to ensure product design teams’ use of critical thinking. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. He or she shall ensure that the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and su...

JOB SUMMARY: Under direct supervision, audit Medline suppliers’ quality management system per applicable regulations CORE JOB RESPONSIBILITIES: 1) Audit Medline Asia suppliers per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017/745, ISO9001, ASTM standards and etc. 2) Prepare Audit reports post audit as a part of Audit Compliance & also perform pre- assessment audit support. Draft and publish audit reports in high quality and timely. 3) Conduct adequate CAPA follow-up and evidence review for supplier in a timely manner 4) Provide supports and guidance for vendors in improving the quality management system per Medline internal audit ...

Role Objective Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements. The role ensures timely preparation and updating of Technical Master Files, supports product registrations, manages post-market surveillance activities, and contributes to audit readiness. This position requires close collaboration with internal stakeholders to ensure consistent regulatory compliance across the organization. Desired Candidate Profile Graduate/Postgraduate in Pharmacy, Biotechnology, Life Sciences, or a related discipline. 6–9 years of experience in Regulatory Affairs, preferably in the pharmaceutical,...

Job Title: QA/QC Engineer – Process Equipment Department: Quality Assurance / Quality Control Reports To: QA/QC Manager / Project Quality Manager Location: Site Job Purpose: To ensure that all process equipment (e.g., pressure vessels, heat exchangers, columns, tanks, reactors, etc.) are fabricated, assembled, inspected, and tested in accordance with the applicable codes, client specifications, and project quality standards. Key Responsibilities: Review and Approve Quality Documents: Review ITPs (Inspection and Test Plans), QCPs (Quality Control Plans), WPS/PQR (Welding Procedure Specification / Procedure Qualification Record). Ensure compliance with ASME, API, and other relevant codes and s...

Job Purpose: Responsible for updating QMS procedures, creating new documents and updating Quality Manual with regard to latest guidelines/regulatory requirements/applicable product standards. Responsible for product submissions – domestic and international, registration renewals, seeking periodic updates and dossier preparation for regulatory agencies. Organize regulatory information, track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide and research regulatory issues and provide guidance to colleagues. Functional Responsibilities: Timely compile Product Technical Files/ QA record...

Job Title Senior Project Manager Job Description Senior Project Manager As a Senior Project Manager, you will lead the execution of complex, large-scale projects that drive global sourcing strategies and deliver on strategic business objectives. Your focus will span supplier management, end-to-end product launch execution, lifecycle oversight, and sustaining engineering initiatives. You are responsible for Leading the execution of large-scale projects that drive global sourcing strategies to deliver the strategic business initiatives. This includes supplier management, E2E product launch management, and lifecycle management, among other critical sustaining engineering activities. Responsible...

Key Responsibilities Provide quality support to design and development teams. Review and approve design control documents (DHF, DMR, Risk Management File). Ensure compliance with ISO 13485, ISO 14971, and applicable regulatory standards. Participate in design reviews and risk assessments. Support verification, validation, and design transfer activities. Drive continuous improvement in design quality processes. Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing, and Post-Market). Qualifications Bachelor’s degree in Mechanical Engineering or related field. 7+ years’ experience in Design/Development Quality in the medical device industry. Strong understanding of ISO 13485, ...

Roles & Responsibilities Manage and maintain the QMS, ensuring compliance with global medical device regulations. Lead internal and external audits; ensure timely closure of findings. Oversee document control, CAPA, training, and change management processes. Monitor quality metrics and drive continuous improvement initiatives. Support regulatory inspections, product registrations, and management reviews. Collaborate with cross-functional teams to ensure quality integration in all processes. Train and mentor team members on QMS requirements and best practices. Qualifications Bachelor’s/Master’s in Engineering, Mechanical or related field. 7+ years’ experience in Quality Assurance, with 3+ yea...

You will be responsible for the following tasks in the role: - Act as the primary onsite point of contact between the customer and GWCs MDR/SOC teams. - Coordinate and track incident response activities, including triage, validation, and escalation. - Support onboarding of new log sources, asset visibility updates, and configuration changes for SIEM, SOAR, and MDR workflows. - Review and validate security alerts, incident tickets, and reports generated by the MDR platform. - Provide insights on incident trends, threat patterns, and participate in customer review meetings. - Ensure timely communication of critical incidents to key stakeholders. - Maintain and update operational documentation ...

Key Responsibilities Provide quality support to design and development teams. Review and approve design control documents (DHF, DMR, Risk Management File). Ensure compliance with ISO 13485, ISO 14971, and applicable regulatory standards. Participate in design reviews and risk assessments. Support verification, validation, and design transfer activities. Drive continuous improvement in design quality processes. Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing, and Post-Market). Qualifications Bachelor’s degree in Mechanical Engineering or related field. 7+ years’ experience in Design/Development Quality in the medical device industry. Strong understanding of ISO 13485, ...

Role Overview: You are sought after to fill the position of an Enterprise Account Manager at Sophos. In this role, you will be responsible for leading strategic engagements with top enterprise accounts in the Bangalore region. Your main tasks will include driving growth across large, strategic enterprise accounts, positioning end-to-end cybersecurity solutions, building strong executive relationships, leading the full sales cycle, collaborating with internal stakeholders, accurately forecasting pipeline and revenue, and representing the brand at industry events and strategic forums. Key Responsibilities: - Drive growth across large, strategic enterprise accounts in Bangalore and surrounding ...

Job Description Job Title Data Analyst Job Description Job Title : Data Analyst Job Responsibilities Executes low complexity post market surveillance processes, adheres to predefined parameters and guidelines, optimizes efficiency and effectiveness, and fosters consistency and reliability in operations to maintain a high level of quality and performance within the established framework of operational procedures. Conducts operations and reporting procedures to ensure efficient tracking and monitoring of execution progress, enabling effective decision-making and resource allocation aligned with strategic goals. Develops and delivers comprehensive reporting tools to facilitate informed decision...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...

Job Description We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specifically responsible for t...