Executive – Regulatory Affairs

6 months ago


Chennai, India TTK Healthcare Full time
Reporting to: Assistant Manager – Regulatory Affairs Division: Ortho Implants Location: Chennai No. of Positions: 1 Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory Affairs Experience: 2 - 4 years Exp. in ‘scientific writing / clinical documentation’ role preferred KEY RESPONSIBILITIES: Technical writing, literature search, review, data extraction, Data Analysis and appraisal as per guidelines for medical devices (Class III) Scientific development and template preparation for protocols and procedures, related to ortho implant surgeries during piloting phase as well post-marketing surveillance studies. DESIRED CANDIDATE PROFILE: Experience in ‘scientific writing/clinical documentation’ role. Exposure to medical device regulatory affairs, is preferable. Proficiency in English, Proof reading skills and MS Office skills mandatory. Knowledge of any other document/image editing software is a plus. Possesses logical, analytical and verbal skills.

  • Ambattur, Chennai, Tamil Nadu, India Gesco Healthcare Pvt Ltd Full time

    Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...


  • Ambattur, Chennai, Tamil Nadu, India Gesco Healthcare Pvt Ltd Full time

    Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...


  • Ambattur, Chennai, Tamil Nadu, India Gesco Healthcare Pvt Ltd Full time

    Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...


  • Chennai, Tamil Nadu, India MNR Solutions Private Limited Full time

    **Hi ,** **Urgent opening for Regulatory affairs -Executive** **Hiring **:Regulatory affairs -Executive **Location: - Chennai / Dehradun** **Experience: - 5+Years** **Notice Period: - 0-15 Days** **Industry : Pharma** **Qualification : M Pharma / B Pharma** ( **Knowledge of ROW, Emerging market, ZAZIBONA and EU market requirements and ICH guidelines...


  • Guindy, Chennai, Tamil Nadu, India Tekna Manufacturing Full time

    We are in the process of hiring Regulatory Affairs **Job Title**: Regulatory Affairs Executive **Key Responsibilities**: **Qualifications**: Bachelor Degree in a related field such as Biomedical engineering, Mechanical engineering with minimum of 2 years’ progressive Regulatory affairs experience in medical device & quality...


  • Guindy, Chennai, Tamil Nadu, India Tekna Manufacturing Full time

    We are in the process of hiring Regulatory Affairs **Job Title**: Regulatory Affairs Executive **Key Responsibilities**: **Qualifications**: Bachelor Degree in a related field such as Biomedical engineering, Mechanical engineering with minimum of 5 to 7 years’ progressive Regulatory affairs experience in medical device & quality...


  • Perungudi, Chennai, Tamil Nadu, India sarvsri the food company Full time

    **Job description** We are looking for a motivated and experienced Regulatory Affairs Specialist to join our team! As a Regulatory Affairs Specialist, you will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is...

  • Regulatory Affairs

    3 weeks ago


    Bengaluru / Bangalore, Chennai, India Ajay Bhardwaj (Proprietor Of Ocean Biomed) Full time

    Summary:The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.Roles and Responsibilities:Regulatory Submissions: Prepare and submit regulatory documents for product approvals and...


  • Tambaram, Chennai, Tamil Nadu, India Regenix Biosciences Ltd Full time

    **Experience**: 1 to 2 years of experience in Regulatory affairs. **Qualification**: B. Pharm / M. Pharm / MSc. Biotechnology **Description**: - Regulatory Affairs - Handling Dossiers - License - Queries - CFT Communication - Life cycle etc. **Immediate Joiners** Excellent in Communication **Job Types**: Full-time, Permanent Pay: Up to ₹28,000.00...


  • Perungudi, Chennai, Tamil Nadu, India MORULAA HEALTH TECH PVT LTD Full time

    Job Summary The Regulatory Affairs Specialist is responsible for ensuring compliance with all applicable regulations governing the development, manufacturing, and distribution of the company's products. This role involves collaborating with internal teams and regulatory agencies to facilitate product registrations, approvals, and adherence to quality...


  • Chennai, Tamil Nadu, India ClinChoice Full time

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice, is searching for an Executive - Regulatory Affairs (PLMDS) to join one of our clients. **Main Job Tasks and Responsibilities**: - Complete...


  • Chennai, India Guires Solutions Pvt Ltd Full time

    **Industry** Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific Communications **Position** Full Time, Permanent **Division** Pubrica Brand **Reports to**: Pubrica Business Head **About Company** Guires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot...


  • Karapakkam, Chennai, Tamil Nadu, India CellBios Healthcare & Lifesciences Pvt. Ltd Full time

    **Key Responsibilities**: - **Regulatory Compliance**: Ensure compliance with ISO 13485, EU MDR 2017/745, US-FDA, CDSCO, and other applicable international standards for medical devices. - **Submissions and Approvals**: Prepare, review, and submit regulatory documentation, including 510(k) and IMDR submissions, to regulatory authorities such as US-FDA,...


  • Egmore, Chennai, Tamil Nadu, India International Ingredients & Excipients Pvt Ltd Full time

    **Job highlights** - Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science. Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm. - Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation **Job description** This is a...


  • Perungudi, Chennai, Tamil Nadu, India Morulaa HealthTech Pvt LTd Full time

    **Key Responsibilities**: - Monitor and stay up-to-date on regulatory changes and requirements in different regions. - Communicate with regulatory authorities and answer their queries or requests. - Ensure product labeling and packaging meet regulatory standards. - Maintain records of regulatory submissions, approvals, and correspondence. - Support product...


  • Chennai, Tamil Nadu, India Pfizer Full time

    About Us\Pfizer is a world-leading pharmaceutical company that strives for excellence and integrity in its operations. We aim to bring medicines to the world faster, while adhering to local and global regulations. As a forward-thinking organization, we require attention to detail and dedication from our team members.\Your Role\You will be responsible for...


  • Chennai, Tamil Nadu, India Pfizer Full time

    Company OverviewPfizer is a global pharmaceutical company that aims to bring medicines to the world faster, while maintaining excellence and integrity.About the RoleWe are seeking a Regulatory Affairs Specialist to join our team in On Premise. As a key member of our regulatory affairs team, you will play a critical role in providing strategic product...


  • Chennai, Tamil Nadu, India Bio-Rad Laboratories, Inc. Full time

    About the RoleAs a Regulatory Affairs Specialist at Bio-Rad Laboratories, you will play a critical role in ensuring compliance with regulatory requirements for the importation and supply of biologicals and other controlled products in India. This position requires a strong understanding of regulatory frameworks, attention to detail, and excellent...


  • Chennai, Tamil Nadu, India TTK Healthcare Full time

    We are seeking a skilled Regulatory Affairs Specialist to join our team at TTK Healthcare. In this role, you will be responsible for ensuring compliance with regulatory requirements for medical devices, specifically Class III products.Job Summary:Technical writing and data analysis as per guidelines for medical devicesScientific development of protocols and...


  • T Nagar, Chennai, Tamil Nadu, India Sishya Meditech Pvt Ltd Full time

    General Accountability Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files. **Responsibilities**: 1. Write, analyze, and edit...