Medical Device Manufacturing jobs
- Shinelife Meditech LLPKalyan, Maharashtra
- Responsible for complete regulatory activities for Medical Devices in India (CDSCO, State FDA).
- Preparation and submission of dossiers for Import License,…
- Provost ContrivesKharadi, Pune, Maharashtra
- Strong experience in Medical device design.
- Medical device development experience will be an advantage.
- Mechanical design experience in *plastic, metal &…
- DNA XpertsVisakhapatnam, Andhra Pradesh
- Experience in handling operations of medical devices preferred.
- Incumbent will be responsible for production of Microbiology Manufacturing unit, Real Time PCR…
- Saaki Argus & Averil ConsultingPune, Maharashtra
- The Systems Engineer will support EU MDR 2017/745 remediation programs for Class I, II and III medical devices.
- Shivashakti Group of CompaniesAjmer, Rajasthan
- Experience Required : 2 to 5 + years.
- Shivashakti Group of CompaniesAjmer, Rajasthan
- Experience Required : 2 to 5 + years.
- St. Stone Medical Devices Privted LimitedKakching, Manipur
- Knowledge of medical device manufacturing/QMS.
- We are looking for an experienced Plant Head to lead and manage our medical device manufacturing plant.
- UpTyeHyderabad, Telangana
- The ideal candidate must be someone with hands-on shop floor experience in a regulated manufacturing environment, preferably involving *injection moulding,…
View similar jobs with this employerAviyana Ventures Pvt. Ltd.Palghar, Maharashtra- 2–5 years of experience in Quality Assurance within the healthcare equipment or medical device industry.
- We are seeking a detail-oriented QA Executive to ensure…
- Fresenius Medical CareBengaluru, Karnataka
- Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling.
- Integrated Assessment Services Pvt LtdChennai, Tamil Nadu
- Support medical device documentation, laboratory documentation and accreditation requirements.
- Support assessment of medical device quality systems, risk…
- Madhu InstrumentsOkhla Industrial Area Phase-i, Delhi, Delhi
- 3–5 years of experience in Regulatory Affairs / Quality Assurance within the medical device or healthcare sector.
- Clarity medical pvt ltdChandigarh
- 12–18+ years of experience in Regulatory Affairs within the medical device industry.
- Experience with Class II/III or higher-risk medical devices will be an…
- Novintix Technologies LimitedAndra, Andhra Pradesh
- Ensure engineering activities comply with applicable medical-device regulations and standards.
- Develop and maintain mechanical designs for medical-device…
- NeST DigitalBengaluru, Karnataka
- Responsible for 3D model creation and drawing development of designs for new mechanical subsystems used in medical devices.
- DEKRA Process SafetyIndia
- Experienced in at least one of the following devices categories and areas of expertise: Active medical devices, Active implantable medical devices, soft tissue…
- View all DEKRA Process Safety jobs - India jobs
- Salary Search: Medical Device Expert salaries
Medical Device regulatory affairs
Medical Device regulatory affairs
Job details
Pay
Job type
Benefits
Full job description
Job Title: Executive / Manager - Regulatory Affairs (Medical Devices)*
*Company: Shinelife Meditec LLP - Bhiwandi, Maharashtra*
*Experience: 2 - 6 Years in Medical Device*
*Qualification: B.Pharm / M.Pharm / B.E Biomedical / M.Sc*
*Job Description:*
*1. Regulatory Compliance:*
- Responsible for complete regulatory activities for Medical Devices in India (CDSCO, State FDA).
- Preparation and submission of dossiers for Import License, Manufacturing License, MD-14, MD-15, Test License MD-13, MD-17 etc.
- Knowledge of Medical Device Rules, 2017 & its amendments.
*2. Documentation:*
- Preparation, review and compilation of Device Master File (DMF), Plant Master File, and other technical documents.
- Ensure compliance with ISO 13485, ISO 14971, and QMS requirements.
*3. Licensing & Coordination:*
- Liasoning with CDSCO, Notified Bodies, and consultants for timely approvals.
- Handling SUGAM portal activities.
- Maintaining regulatory licenses and timely renewals.
*4. Product Registration:*
- Support for international registrations - USFDA, EU MDR, ASEAN countries will be added advantage.
- Labeling review as per regulatory requirements.
*5. Other Responsibilities:*
- Support QA/RA for audits, CAPA, and risk management.
- Keep updated with latest regulatory guidelines.
*Required Skills:* Strong knowledge of CDSCO, SUGAM, Medical Device Rules 2017, ISO 13485, Good Documentation Practice.
Pay: ₹300,000.00 - ₹360,000.00 per year
Benefits:
- Provident Fund
Work Location: In person