Regulatory Affairs Professional
7 hours ago
**Internal Title**:Regulatory Affairs Professional
**External Title**:Deputy General Manager
**Position Summary**
This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's diagnostic imaging & therapy medical devices to be sold in India.
This position will also ensure compliance to the applicable regulatory requirements for these devices in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan & Maldives.
- Responsible to obtain new wholesale license of medical devices from state FDA, renew/amend existing license as required.
- Perform post market surveillance compliance & reporting for the registered devices.
- Coordinate with CS & logistics team to get the Field Safety Corrective Actions implemented for devices.
- Support buss. partners in zone countries like Bangladesh, Sri Lanka, Nepal, Maldives & Bhutan to fulfill regulatory requirements related to Medical devices.
- Perform Quality system audits of suppliers, service agencies and business partners.
- Maintain documentation related to all above topics including progress & record trackers.
- Keep abreast on updates/ changes to applicable regulations & requirements for the devices and represent SHPL at industry forums on regulatory topics.
**Experience and Qualification**:
- BPharm/ MPharm/ BTech/ MTech/ BSC/ MSc with 8-10 years’ experience of pre-market & post market regulatory work on compliance to Medical Device Rules (MDR) 2017, Drugs & Cosmetics Act & Rules governed by Central Drug Standard Control Organization (CDSCO) & state FDA for diagnostic imaging & therapy medical devices including Software medical devices.
- Should have knowledge about Medical device regulations in EU & USA, Bangladesh, Sri Lanka.
- Good communication & interpersonal skills.
**Organization**: Siemens Healthineers
**Company**: Siemens Healthcare Private Limited
**Experience Level**: Mid-level Professional
**Full / Part time**: Full-time
-
Regulatory Affairs Professional
7 hours ago
Gurgaon, India Siemens Mobility Full timeInternal Title: Regulatory Affairs Professional External Title: Deputy General Manager Position Summary This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's diagnostic imaging & therapy medical devices to be...
-
Associate- Regulatory Affairs
36 minutes ago
Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 5,00,000 - ₹ 12,00,000 per yearJob PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.Key...
-
Associate- Regulatory Affairs
2 days ago
Gurgaon, Haryana, India DDReg Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per yearDDReg PharmaDDReg PharmaFull TimeGurgaonPosted 14 minutes agoJob Purpose:We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier...
-
Global Regulatory Professional
4 days ago
Gurgaon, India GE Healthcare Full time**Job Description Summary**: As a Global Regulatory Affairs professional with expertise within Regulatory Affairs marketed products you will be supporting Marketing Authorisation activities from a full lifecycle management perspective, offering technical expertise and obtaining relevant approvals where required. You will be responsible for providing support...
-
Regulatory Affairs Associate
2 days ago
Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJOB PURPOSE:We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support globalregulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.Key...
-
Country Regulatory Affairs Manager
1 week ago
Gurgaon, India Glanbia Full timeWe are seeking a highly experienced and detail-oriented Regulatory Affairs professional to manage regulatory compliance for our Sports Nutrition portfolio across India and international markets. This individual contributor role involves reviewing product formulations, labels, and claims, ensuring alignment with FSSAI and global regulatory frameworks, and...
-
Regulatory Affairs Intern
1 week ago
Gurgaon, Haryana, India Philips Full time ₹ 4,00,000 - ₹ 6,00,000 per yearJob TitleRegulatory Affairs InternJob DescriptionYour role:Tracking and establishing Process of PC& PNDT (Pre Conception & Pre Natal Diagnostic Techniques) regulations at the District / State level for the sale / supply / demonstration of medical devices that come under PC& PNDT regulations.Tracking and establishing Process of AERB (Atomic Energy Regulatory...
-
Assistant Manager- Regulatory Affairs
1 day ago
Gurgaon, Haryana, India Johnson & Johnson Full timeAt Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full...
-
Senior Manager-Regulatory Affairs-EU/US
2 weeks ago
Gurgaon, Haryana, India DDReg Pharma Full time ₹ 12,00,000 - ₹ 36,00,000 per yearFull TimeGurgaonPosted 4 hours agoSr. Manager-Regulatory Affairs- US/EUExperience: -15+ YearsLocation: GurgaonWe are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks. The role will drive regulatory strategy, dossier submissions, and lifecycle management activities...
-
Drug Regulatory Affairs Specialist
2 days ago
Gurgaon, Haryana, India Sam Global Bio care Pvt. Ltd. Full time ₹ 3,00,000 - ₹ 3,60,000 per yearCompany: Sam Global Biocare Pvt. Ltd.Location: Gurgaon (Gurugram), Sector 67, HaryanaJob Description:Sam Global Biocare Pvt. Ltd. is looking for a skilled Drug Regulatory Affairs Specialist with a strong understanding of international regulatory guidelines. Our focus is on exporting to the Middle East and expanding into African markets, so familiarity...