Regulatory ManagerNulife • mumbai city, India
Regulatory Manager
Nulife • mumbai city, India
10 hours ago
Job descriptionMaintain regulatory files and update regulatory authorizations, such as euMDR, 510(k), UCKA PPE & medical device licenses. etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes, and Support approval in other regions as required. Ensure the Quality Management System complies with the Drugs and Cosmetics Act, Medical Device Rule 2017 & Medical Device Regulations, and is effectively established, maintained, and efficient. Manage internal and external audits, inspection readiness, and Regulatory Authority inspections. Ensuring personal and company compliance with local regulations, policies, and procedures. Managing the complete PMS (post-market surveillance) process. Managed product and process risk management, clinical evaluation, product verification, and validation. Provide training to concerned employees related to ISO, MDR, GMP, PPE and Medical device regulations as per EU and assessment. Assess device-related incidents / complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities on time. Handle recalls and field actions, if required. Review and approve translations of product labelling (e.g., labels, IFU, user manual) and promotional material (external and internal communication). Understand local labelling requirements and ensure all activities related to product labelling are performed correctly. Ensure compliance with Environmental regulations.
Skills & Knowledge
Educational Qualifications
- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
- Audit management euMDR, ISO13485 and 510K.
- Minimum 10 years of related experience
Relevant (functional / Level) and total years of experience
Create a job alert for this search
Regulatory Manager • mumbai city, India
Related jobs
Manager – Legal & Compliance
SuperOps • Mumbai, IN
SuperOps is a SaaS startup empowering IT service providers and IT teams around the world with technology that is cutting-edge, future-ready, and powered by AI.
We are backed by marquee investors lik...Show more
Last updated: 15 days ago • Promoted
Head of Regulatory Affairs
Inventia Healthcare Limited • Mumbai, Maharashtra, India
Inventia is into pharmaceutical development and manufacturing from last 40 yrs.We partner with pharma companies to research, develop, manufacture and distribute OSD.
Our Manufacturing plant is in Am...Show more
Last updated: 7 days ago • Promoted
Torrent Pharmaceuticals - Regulatory Affairs Specialist - MALTA
TORRENT PHARMACEUTICALS LTD • International, India
Description : We are looking for an experienced Regulatory Affairs Specialist to support management and continuous improvement of regulatory proces...Show more
Last updated: 30+ days ago • Promoted
Global Regulatory Manager
Novartis • Mumbai, Maharashtra, India
Directs the development of submission of product registration progress reports supplements amendments and / or periodic experience reports.
Provides strategic product direction to teams on interaction...Show more
Last updated: 30+ days ago • Promoted
Senior Manager, Regulatory Affairs
Visa • Mumbai, Maharashtra, India
The India & South Asia (INSA) cluster covers 6 markets divided into three sub-regions (India Bangladesh / Nepal / Bhutan and Sri Lanka / Maldives) with a total population of approximately 1.Visa has ...Show more
Last updated: 5 days ago • Promoted
Compliance : Retail Advisory
Piramal Finance • Mumbai, Maharashtra, India
Regulatory Advisory : Incumbent will be responsible for providing regulatory clarifications to internal stakeholders and ensuring adherence to all regulatory requirements of the RBI and internal pol...Show more
Last updated: 14 days ago • Promoted
Regulatory Affairs Specialist – (APAC & RoW)
vueverse. • Mumbai, IN
Regulatory Submissions & Compliance.Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, ...Show more
Last updated: 27 days ago • Promoted
Manager / Sr Manager Regulatory Affairs– US Markets
Umedica Laboratories Private Limited • Navi Mumbai, Maharashtra, India
UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.
Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufa...Show more
Last updated: 30+ days ago • Promoted
Manager Regulatory Affairs(PLCM)
APOTEX • Mumbai, Maharashtra, India
Canadian-based global health company that produces high-quality affordable medicines for patients around the world.Apotex employs almost 7200 people worldwide in manufacturing R&D and commercia...Show more
Last updated: 1 day ago • Promoted
Associate Regulatory Operations Intake & Horizon Scanning
JPMorganChase • Mumbai, Maharashtra, India
Join our global Regulatory Operations team to play a crucial role in ensuring compliance with complex regulatory requirements.
Collaborate with cross-functional teams to support the strategic agenda...Show more
Last updated: 27 days ago • Promoted
Assistant Manager
Glenmark Pharmaceuticals • Navi Mumbai, Maharashtra, India
Designation : Assistant Manager – Regulatory Affairs CMC.Reporting to : Deputy General Manager.The Assistant Manager – Regulatory Affairs will be responsible for managing and coordinating regulatory ...Show more
Last updated: 26 days ago • Promoted
Regulatory & Packaging Compliance Specialist
PackIntelX • Mumbai, IN
PackIntelX is building the world’s most intuitive digital platform to help companies navigate EU Packaging & Packaging Waste Regulation (PPWR), Recyclability criteria, Recycled Content requirements...Show more
Last updated: 3 days ago • Promoted
Regulatory Affairs Manager
Glenmark Pharmaceuticals • Navi Mumbai, Maharashtra, India
Highly experienced in submission of initial dossier and deficiency responses to US, EU, UK, Canada and Australia Agency for injectable and ophthalmic products.
Hands-on experience in co-ordination a...Show more
Last updated: 10 days ago • Promoted
UMEDICA Laboratories - Senior Manager - Regulatory Affairs
UMEDICA LABORATORIES PRIVATE LIMITED • Navi Mumbai, India
About UMEDICA : UMEDICA Laboratories is an industry leader in the development, manufacturing, and export of high-quality pharmaceutical formulations.
With decades of operational ...Show more
Last updated: 8 days ago • Promoted
Assistant Manager – Regulatory Affairs
Orion Pharma • Mumbai, Maharashtra, India
We have vacancy for Global Regulatory Expert role in Regulatory Affairs team.We are looking for Assistant Manager.This individual will be based in Mumbai / Hyderabad.
The candidate has the possibilit...Show more
Last updated: 19 days ago • Promoted
Regulatory Affairs Specialist
Illusion Dental Laboratory • Mumbai, Maharashtra, India
Years of Experience : 1-4 years.Working Days : Monday to Saturday.We are seeking a motivated and detail-oriented.The ideal candidate will be responsible for preparing and maintaining regulatory docum...Show more
Last updated: 1 day ago • Promoted
Regulatory Operations Expert
Fortrea • Mumbai, Maharashtra, India
Perform various project management and regulatory affairs activities for Fortrea team including performance reviews human resource issues and assist Senior Management in assigning resources to pro...Show more
Last updated: 30+ days ago • Promoted
Technical Associate – Regulatory Affairs
Genpact • Mumbai, Maharashtra, India
Ready to shape the future of work.At Genpact we dont just adapt to changewe drive it.AI and digital innovation are redefining industries and were leading the charge.
Genpacts AI Gigafactory our indu...Show more
Last updated: 30+ days ago • Promoted