Regulatory Affairs Associate

3 hours ago

Delhi, Delhi, India Datt Mediproducts Pvt. Ltd. Full time ₹ 12,00,000 - ₹ 24,00,000 per year

 Experience in medical device regulatory document preparation including Clinical Evaluation Report, Post-Market Surveillance Report, Post-Market Clinical Follow-up Plan/Report, Periodic Safety Update Report (PSUR) for Medical devices, Summary of Safety and Clinical Performance (SSCP) Report etc.

 Skilled in Materiovigilance activities and reporting in database.

 Proficient in using PV tools.

 Thorough knowledge of regulatory requirements for EU-MDR, USA FDA, SFDA, TGA and MDSAP.

 Familiarity with the principles of clinical research

 Developing technical content that is compliant with ICH, GLPs, and GCPs guidelines.

 Ability to communicate scientific or medical information in a clear and concise manner.

 Proficiency in Word, Excel, PowerPoint, email, and the Internet especially scientific literature search.

 Contribute to document quality control (reviewing data accuracy, formatting and appropriateness of language, and compliance to industry guidelines)

 Ensuring the accuracy of all information, data and referencing for the publications/documents produced

 Being proactive in tracking projects and determining timelines

 Working on a diverse projects at the same time

Qualifications

 A Master's degree or PhD in relevant life science field (Pharmacology, biological sciences, biomedical sciences or biochemistry, or a closely related subject) with 2-3 years of experience.

 Prior experience in regulatory field in an agency/ CRO/ academic/ industry environment preferred.

 Familiarity with industry principles that are relevant to the organization, such as drug safety, regulatory guidelines or pharmacology.

 Knowledge in Medical Device regulatory process and regulations.

 Experience in conducting focused literature searches on PubMed, Embase, MedLine or similar medical literature databases.

 Experience in conducting focused searches on pharmacovigilance and materiovigilance databases.

 Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association.

 Understanding of global regulatory agencies and regulatory processes concerning medical devices.

 A strong work ethic and a solution-focused attitude combined with intellectual curiosity and creativity.

 Ability to multitask and work effectively in teams in a fast-paced, dynamic and creative environment.

  • Regulatory Affairs Manager

    5 hours ago

    Delhi, Delhi, India 45a234db-9cee-4aa6-9b54-37e42d14dee3 Full time ₹ 9,60,000 per year

    Strong knowledge of regulatory affairs principles, regulations, and guidelines, particularly in the relevant industry.Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.Provide regulatory guidance and support to internal stakeholders, including product...

  • Regulatory Affairs Manager

    4 days ago

    Delhi, Delhi, India Ace Cathtech Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 9,00,000 per year

    Company DescriptionAce Cathtech Pvt Ltd, established in April 2024, is a cutting-edge manufacturer of premium medical devices, specializing in Nephrology Products, Cardiac Surgery Equipment, Critical Care, and Anesthesia Products. Located in Faridabad, Haryana, our state-of-the-art facility adheres to the highest manufacturing standards, including a Class 7...

  • Executive Export Regulatory Affairs

    2 weeks ago

    Delhi, Delhi, India Hamdard Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    EXECUTIVE -REGULATORY AFFAIRS Export Regulatory Affairs will be responsible for managing and coordinating regulatory submissions, product registrations, and compliance activities for international markets. This role ensures that all documentation and submissions meet the regulatory standards and timelines of target export countries, while supporting business...

  • Regulatory Affairs Specialist – BIS

    2 days ago

    Delhi, Delhi, India ELT Corporate Private Limited Full time ₹ 2,00,000 - ₹ 12,00,000 per year

    Company:ELT Corporate Pvt. Ltd.Location:Rohini, Delhi (on-site)Experience:1–3 YearsEmployment Type:Full-TimeCompany DescriptionELT Corporate Pvt. Ltd. is a leading regulatory affairs and compliance consulting firm offering end-to-end services in BIS certification, NABL accreditation, CDSCO registration, EPR authorization, WPC license, and FDA regulatory...

  • Manager - Corporate Affairs (Policy & Media Coordination)

    7 days ago

    Delhi, Delhi, India Maruti Suzuki Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Position:DM / MGRFunction:Corporate Affairs (CPA)Experience:~3-7 years (preferably in the auto industry)Location:Maruti Suzuki Head Office, Vasant KunjRole Overview:We are looking for a dynamic, sharp, and self-driven professional to join our growing Corporate Affairs team. The role involves translating complex automotive policy issues into clear, compelling...

  • Validation Associate

    2 weeks ago

    Delhi, Delhi, India Tupalin Research (CRO) Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionTupalin Research is a full-service Contract Research Organization (CRO) providing comprehensive support for clinical trials, regulatory affairs, data management, and real-world evidence. The company is based in Delhi NCR, India, and serves global clients. With a dedicated team of experienced professionals and a strong commitment to...

  • Medical Affairs Manager

    2 weeks ago

    Delhi, Delhi, India Gadgeon Medical Systems Pvt Ltd. Full time

    About WebcardioWebcardio is a leading provider of innovative cardiac monitoring solutions, offering Doctors and patients real-time, remote cardiac diagnostics through advanced wearable ECG technology. Our mission is to improve cardiac care delivery using AI driven insights and seamless technology.Role OverviewThe Medical Affairs Manager will lead and oversee...

  • Regulatory Affairs Assistant Manager

    1 week ago

    Delhi, Delhi, India abca10e5-b8f0-4661-b869-ae7e93dad3ac Full time ₹ 4,50,000 - ₹ 5,00,000 per year

    Job Description:New submissions:a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.Approval : Review & prepare response to deficiency enabling...

  • Urgent opening For Regulatory Profile _New Delhi

    7 days ago

    Delhi, Delhi, India Narula Exports Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Prepare and submit regulatory submissions, including product registrations, variations, renewals, and licenses to various Authorities in different countries. Apply and manage CDSCO licenses (e.g., ISO 13485, MDR 2017/745, US FDA, etc.). Required Candidate profileExcellent written and verbal communication skills with the ability to produce high quality...

  • Strategic Affairs

    7 days ago

    Delhi, Delhi, India Avaada Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Job Description: -Relationship-building, liaison, and obtaining licences, permits, and approvals related to the company's business.The ability to coordinate with statutory organisations, such as Mantralaya, State Departments (Energy, Revenue, Home, Industry, State Nodal Agencies, SLDCs), and Local Administration (at the district level), to carry out...