Officer/ Executive
2 weeks ago
1)Preparation of Quality Manual as per updated ISO 13485:2016 and ISO 9001:2015 2) Review and update change controls related to NPD Projects (New Product Development) and other required change 3) Preparation of Dossiers for Semi-Regulated market and Non-Regulated market according to CTD format and ACTD. 4) Prepare Site master file and device master file as per Indian MDR. 5) Preparation of Clinical evaluation report (CER), Risk management analysis, Review and update Essential requirement report (ESR). 6) Maintaining the CDSCO portal for Product registration, filling document submission, and license 7) Preparing new product marketing submission for FDA i.e. 510K and Premarket Approval (PMA). 8) Preparation of documents for brand registration a local FDA. Also having an Exposure and Compliance of EUMDR. 9) Preparation of dossier for medical devices, Risk Management documents as per ISO 14971:2012 (Risk Management plan, Risk Management Assessment, FMEA, and Risk Management Report). 10) Handling of Market Customer Complaints & Preparation and verifications of Tender Documents (Quality Section). 11) Good understanding of medical device standards, guidelines and regulations 11.1) Quality Management System (ISO 13485). 11.2) Risk Management System (ISO 14971). 11.3) Medical Device Regulation (EU MDR). 11.4) Food and Drug Association (US FDA 21 CFR part 820.30) 12) Responsible for ISO 13485 audit, CDSCO approved private bodies audit for Class A & Class B Medical products & CDSCO audit for Class C products. 13) Responsible for obtaining regulatory certifications such as non-conviction Certificate, Market Standing Certificate & Free Sale certificate. 14) Preparing the Technical Literature of any New Product development (Predicate and Innovator Devices) 15) Up to date on All the regulatory rule, norms, guidelines & clause changes across the globe w.r.t Ami Polymer Medical devices in CDSCO portal or other country "Sealing Expert.in Silicone 16) Responsible for Product/Device Listing & monitoring on daily basis in Global platforms (Regulatory market) - US, EU, UAE, ROW etc. 17) Preparation of SOP as per updated Standards and regulatory requirements. 18) Knowledge about Product validation and Testing of the new and existing products. Key Skills: Working experience in Pharmaceutical or Medical devices, knowledge about Testing evaluation and validation of the products, Knowledge about regulatory guidelines like ISO, USFDA, EUMDR, IMDR, Experience about the regulatory product certification and licensing in domestic and Export, Draft Testing protocols and Reports, Knowledge about technical literature search. Pay: ₹250,000.00 - ₹350,000.00 per year **Benefits**: - Flexible schedule - Food provided - Health insurance - Leave encashment - Paid sick time - Provident Fund Schedule: - Day shift Supplemental Pay: - Yearly bonus Work Location: In person
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Office Executive
1 week ago
Dadra, India Spectra Controls Full timeThe role is responsible for the day - to - day operation of Front Office. **Salary**: ₹10,000.00 - ₹15,000.00 per month Schedule: - Day shift **Speak with the employer** +91 8447408087
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Senior Officer
4 weeks ago
Dadra, India SUN PHARMA Full timeJob Title: Senior Officer / Executive – MSTG Orals Business Unit: R&D1 Regulatory Affairs Job Grade G12B/G12A Location Dadra At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to...
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Office Executive
1 week ago
Dadra, India Dreams Management Full timeKey Skills: Qualifications : Any Graduate Experience Required (Years) : From 1 To 5 Years Salary Range (PA) : 120000 To 240000 Location : Dadra Industry Type : Manufacturing Company **Job Description**:
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Dadra, India Ami Polymer Pvt. Ltd Full time**Key Responsibilities**: - **Adhere to GMP and GDP**: - Ensure all activities are performed in accordance with SOP (Standard Operating Procedures) and regulatory requirements for GMP and GDP. - Maintain compliance with safety, quality, and environmental standards during production processes. - **Final Quality Check and Approval**: - Conduct final quality...
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Admin Executive
1 week ago
Dadra, India Shivam Proteco Full time**Manage and organize office operations**: Administrators oversee day-to-day operations, such as managing schedules, coordinating meetings, and handling correspondence. These ensure that your office environment is organized and efficient. - **Maintaining records and databases**: Administrators often handle sensitive information and maintain databases and...
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International Marketing
21 hours ago
Dadra, India Ami Polymer Pvt. Ltd Full time**-Data Management: Managing and organizing customer data, sales reports, marketing analytics, and other relevant information to support decision-making processes.** **- Order Processing: Handling order requests, ensuring timely processing, and coordinating with various departments such as logistics and finance to ensure seamless order fulfilment.** **- All...
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Data Entry Operator/computer Operator
1 week ago
Dadra, India Himadi Solutons Pvt. Ltd. Full timeWe are looking for Female Data Entry Executive, job requirement is mentioned below - This role is a role for professionals who are good with typing speed. - Knowledge of Excel - vlookup, shortcuts, filter and conditional formatting is a must. - Must be able to create reports using data. **Job Types**: Full-time, Permanent, Fresher **Salary**: ₹10,263.06...
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Front Office Executive
2 days ago
Dadra and Nagar Haveli, India Nutan Mishra Full time ₹ 1,50,000 - ₹ 2,50,000 per yearResponsibilities:* Manage front desk operations* Coordinate with production and make plan* Make invoice and manage the delivery* Take care of day to day office operation* Ensure administrative tasks completed*Preferably girlTravel allowanceAccidental insuranceJob/soft skill training
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Senior Officer
2 days ago
Dadra and Nagar Haveli, India Sun Pharmaceutical Industries, Inc. Full time ₹ 5,00,000 - ₹ 15,00,000 per yearTitle: Senior Officer - MSTGDate: Sep 16, 2025Location: Dadra - PlantCompany: Sun Pharmaceutical Industries LtdJob Title:Senior Officer / Executive – MSTG OralsBusiness Unit:R&D1 Regulatory AffairsJob GradeG12B/G12ALocationDadraAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step,...
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Ah Bill Passing
3 days ago
Dadra, India Aditya Birla Group Full time**Designation**:Officer **Updated**:December 26, 2024 **Location**:Dadra and Nagar Haveli, India **Organization**:Metals **1) Job Purpose** Ensuring timely Capex planning and completion, Executing GL with AP and maintaining proper GL balances, ensure timely Bill Passing - Supply, Stores Inventory. Prepare for and complete project...