45 Ce Marking Jobs - Page 2

Job Description Core Skills 15+ years of hands-on software development experience, with 3-5 years in a senior/principal architect role. Proven expertise in C# .NET and/or Java. Flexibility to work across both technologies is strongly preferred. Solid experience in backend architecture including system design patterns, cloud infrastructure, scalability, and reliability. Proficient in cloud-native architectures using AWS (preferred). Experience with Azure or GCP is a plus. Strong foundation in software design principles, design patterns, and clean architecture. Demonstrated experience designing and implementing complex, multi-generation software products. Deep understanding of Healthcare softw...

JOB DESCRIPTION: Job Title: Regulatory Affairs Specialist - Medical Devices Location: New Delhi Department: Regulatory Affairs Reports To: Regulatory Affairs Manager Job Summary: The Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets. This role involves preparing and submitting regulatory documents, maintaining compliance with CDSCO and other global regulatory bodies, and supporting product development teams with regulatory guidance. Key Responsibilities: Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other regulatory authori...

Role: Quality Manager Medical Devices / Pharmaceutical Products Location: Chennai, Tamil Nadu Job Description: We are seeking a skilled Quality Manager to join our team in the medical devices/pharmaceutical sector. The position requires strong experience in quality management systems, regulatory compliance, and cross-functional collaboration across development and manufacturing. Key Responsibilities: Support multiple quality projects across development and commercialization stages Maintain and enhance QMS in line with ISO 13485, 21 CFR Part 820, EU MDR Review technical documentation (DHF, risk files, validation records) Assist in regulatory submissions (510(k), CE marking) Collaborate with c...

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 Us We are a global climate technologies company engineered for sustainability. We create sustainable and efficient residential, commercial and industrial spaces through HVACR technologies. We protect temperature-sensitive goods throughout the cold chain. And we bring comfort to people globally. Best-in-class engineering, design and manufacturing combined with category-leading brands in compression, controls, software and monitoring solutions result in next-generation climate technology that is built for the needs of the world ahead.? Whether you are a professional looking for a career change, an undergraduate student exploring your first opportunity, or recent graduate with an advanced...

As a Documentation & Certification Engineer at SPX FLOW located in Pune, you will play a crucial role in ensuring that all products meet global regulatory requirements, with a specific focus on ATEX, Machinery Directive, and CE Marking compliance. Your responsibilities will include creating, managing, and maintaining technical documentation, certification records, and regulatory submissions. You will collaborate closely with engineering, product development, and quality teams, as well as external notified bodies. Your duties will involve preparing and maintaining comprehensive technical documentation such as Declarations of Conformity, instruction manuals, technical construction files, datas...

Mega Virtual drive for Compliance Engineer for Bangalore location Experience : 5 - 10 Years Work Location : Bangalore No of Positions : 5 Roles & Responsibilities: BE/ ME in Mechanical Engineering with 5 - 10 years of experience in the product compliance with various product regulatory or certification agencies. Should have knowledge about the necessity of international certifications like IEC, IECEx, etc and other country regulatory certification like CSA, UL, TUV, Intertek, CE marking, etc. Basic knowledge in the various directives for the EU requirements for the CE marking. Should have basic design Knowledge in the Pressure equipments like Compressors and its accessories. Basic Knowledge ...

Background Industry: Pharmaceutical Formulations (Injectables) or Medical Devices (EU Class 2b or higher) manufacturing company with turnover higher than 300 Cr Required Skills: Experience in QA management across multiple projects involving the implementation of the Company's QA processes and strategies. The projects include IPQA, QMS, cGMP, validation and Compliance related assignments Ensure that the norms and laws, set by regulatory authorities, are met. Preferentially an audit experience for FDA, EU MDR, PMDA, SFDA, TGA and KFDA requirements Excellent knowledge of QA processes including of risk management, clinical data management and electronic data management systems. Ability to handle...

As a Product Assessor, you will play a crucial role in our organization by overseeing Sterilization product assessments and conducting technical file reviews in strict adherence to regulatory requirements, including the European Medical Device Directive and Medical Device Regulation for Class IIa/IIb and/or Class III. Your primary focus will be to ensure the technical soundness of reviews and compliance with all relevant standards. Responsibilities: Conduct comprehensive Sterilization product assessments in line with regulatory requirements for medical devices. Support CE marking activities conducted by SGS, contributing to the overall certification process. Effectively communicate with coll...

As a Product Assessor you ll conduct technical file reviews to ensure that products are safe and perform as intended in compliance with all applicable requirements including UK and EU medical device regulation. You ll also support CE marking activities and communicate with colleagues and clients regarding product assessment and other activities, working to minimise risks associated with medical device certification. Degree or equivalent experience in medicine, dentistry, biotechnology, engineering or other relevant fields 4+ years of professional experience in the orthopaedic/dental products sector or related fields, covering roles in design, manufacturing, auditing, or research. Crucially, ...

Standards & Codes: ASME Section VIII Div. 1 & 2 ASME Section IX (Welding Qualifications ASME Sec V Welding & NDT: Welding process knowledge (SMAW, GTAW, SAW) WPS/PQR/Welder qualifications Non-Destructive Testing (RT, UT, PT, MT, VT) knowledge Interpretation of NDT results Fabrication & Inspection: Dimensional inspection of shells, heads, nozzles Monitoring fit-up and alignment (e.g., weld mismatch tolerances) Hydrostatic / pneumatic testing procedures Surface preparation and painting/coating inspection Materials: Review of Mill Test Certificates Traceability & material control Handling special alloys (e.g., stainless, Hastelloy) Documentation: Preparing Quality Dossiers / Manufacturers Data ...

1. Maintain the QMS documents on the lines of ISO 13485 and GMP 2. Responsible for control of all levels of documents & their history in accordance with EU MDR 3. Coach and Guide the team to support company goals by : Identifying factors that are critical to prospective and retrospective stability studies Participate in the new product registration/ life-cycle management discussions to provide inputs on the procedure for analysis, mainly validations

Urgent Opening for Compliance Engineer - Hazardous Area Classification Experience : 2 - 7 Years Work Location : Bangalore No of Positions : 2 Bachelors of engineering (BE) in Mechanical/Aeronautical • 3 to 8 years of experience in the field of power plant operation is mandatory • Gas Turbine (GT) Engine operating principles knowledge is Mandatory . Hazardous Area Classification - IECEX Certification • GT Data analysis & Trend analysis experience is advantage • Ability to interact and provide solutions for GT Engine snags is an added advantage • Validation of reports based on established processes for quality and accuracy of content • Quality management within the expected Report publication ...

Position - Marketing Engineer - Product Certification Education - BE/B Tech - Electrical/Electronics/ENTC/Mechanical Experience - 3 to 10 Years Location - Pune Job Responsibilities: Implement marketing ideas on-site for CE marking, ATEX and Functional Safety, Product Identify potential customers through visits to various industrial areas. Generate leads by visits and cold calling Co-ordinate with Sr. Project Leader and support in conversion of lead to sales. Achieve monthly targets Maintain/update funnel of potential clients for Gujarat, Rajasthan & MP. Preference: Should have excellent communication and presentation skills Candidate should be smart, energetic and should be a team player Sho...

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quali...

Job Summary We are looking for a detail-oriented and experienced Quality Control Engineer to join our manufacturing team. The ideal candidate will be responsible for implementing and overseeing quality control processes, ensuring all products meet national and international medical device standards, and working closely with production and R&D to resolve quality issues. Key Responsibilities Conduct in-process and final quality inspections for medical devices in accordance with GMP and ISO 13485 standards. Develop and maintain QC protocols, SOPs, and inspection reports. Ensure compliance with regulatory requirements such as CDSCO, MDR 2017, ISO 13485, and CE. Perform root cause analysis and co...

About Janitri Janitri is a Med-tech company that develops IoT-based smart pregnancy and newborn monitoring devices. Apart from a recent feature in Shark Tank, Janitri has won numerous awards and accolades for its life-saving innovations. About the position: We are seeking a highly motivated and experienced Senior Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product lifecycle of Class II medical devices. This role requires a deep understanding of regulatory affairs, quality management systems, and strong attention to detail. R...

Job Title: Regulatory Affairs Manager Key Responsibilities: Prepare and submit applications for CDSCO (Form MD-14/MD-15), USFDA 510(k), BIS registration, and CE Marking. Manage regulatory audits and inspections (USFDA, CE, ISO 13485, BIS). Ensure compliance with 21 CFR 820 (USFDA), EU MDR 2017/745 (CE), Indian MDR 2017 (CDSCO), and BIS standards. Review technical files, labeling, and promotional material for regulatory compliance. Monitor regulatory changes globally and advise internal teams. Support post-market surveillance, reporting, and product registrations. Requirements: Bachelors/Master’s degree in Pharmacy, Life Sciences, Biomedical, or related field. 7–10 years of regulatory affairs...

POSITION TITLE: Engineer -Compliance Documentation LOCATION: Bellandur REPORTING TO: Engineering Manager JOB PURPOSE & CONTEXT: The Industrial Tooling Compliance Specialist is responsible for leading the process of obtaining and maintaining compliance for a variety of end user tools used in automotive and industrial markets. Candidates should be self-motivated individuals with a strong work ethic that have experience with various compliance regulations including (but not limited to) CE, ANSI, ISO, CSA and UL. Additionally, the ideal candidate will have experience with certification processes globally including regional specific marking requirements including PSE, KC, RCM, EQM, UKCA and NOM. ...

ASME/DIN/AD /EN Codes knowledge ISO System implementation updation Design of Equipment’s - Static, pressure vessels heat exchangers Integration of bought out into vessel Detailing engg Cutting layouts, sector layouts