Jobs
>
Chennai

    HCL is Hiring Regulatory Affairs@Chennai - HCLTech

    HCLTech
    HCLTech background
    Technology / Internet
    Description

    HCL Technologies is a next-generation global technology company that helps enterprises reimagine their businesses for the digital age. Our technology products and services are built on four decades of innovation, with a world-renowned management philosophy, a strong culture of invention and risk-taking, and a relentless focus on customer relationships. HCL also takes pride in its many diversity, social responsibility, sustainability, and education initiatives. Through its worldwide network of R&D facilities and co-innovation labs, global delivery capabilities, and over 197,000+ Ideapreneurs across 52 countries, HCL delivers holistic services across industry verticals to leading enterprises, including 250 of the Fortune 500 and 650 of the Global 2000.

    HCL is Hiring for Regulatory Affair for one of the leading product based client. "Come join us in reshaping the future

    Qualification Required:

    BE/B.Tech/M. Tech/MCA educational background.

    Exp required : 12 to 20 yrs.

    Job Location: Chennai

    Notice Period: max 60 Days

    Key Skill:

    Skill set:

    · Extensive Experience in ISO 13485, ISO 9001, FDA QSR (21-CFR-820), EU-MDR, India-MDR

    · Experience in ISO 14971, IEC 62304

    · Experience in handling QMS for High Risk Programmable Electro-Mechanical Medical

    Devices (US-FDA Class-3 or India MDR-Class-D) (experience with Implantable device is nice to have)

    Use of excel sheet or other statistical tools for Data analysis

    If you are interested in exploring this job profile, please share your updated profile to for detailed discussion.

    How You Wll Grow

    At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

    Why Us

    • We are one of the fastest-growing large tech companies in the world, with offices in 60+ countries across the globe and 222,000 employees
    • Our company is extremely diverse with 165 nationalities represented
    • We offer the opportunity to work with colleagues across the globe
    • We offer a virtual-first work environment, promoting a good work-life integration and real flexibility
    • We are invested in your growth, offering learning and career development opportunities at every level to help you find your own unique spark
    • We offer comprehensive benefits for all employees
    • We are a certified great place to work and a top employer in 17 countries, offering a positive work environment that values employee recognition and respect


  • Healthcare (OHQ) Chennai, India

    **Job Title**:Regulatory Affairs and SCM -Executive · **Location**:Chennai, India**Employment Type**:Permanent**About OMRON** · - Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC ...


  • INTERMED Chennai, India

    Explain regulations, policies, or procedures · - Maintain data in information systems or databases · - Ensure compliance with regulations · - Advise others on regulatory and compliance matters · - Evaluate applicable laws and regulations to determine impact on company activities ...


  • ClinChoice Chennai, Tamil Nadu, India

    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) ...


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

    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 age ...


  • TTK Healthcare chennai, India

    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 d ...


  • Guires Solutions Pvt Ltd Chennai, India

    **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 glob ...

  • Pfizer

    Associate I

    3 days ago


    Pfizer Chennai, India

    Why Patients Need You · We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attentio ...

  • Pfizer

    Rapd Associate I

    3 days ago


    Pfizer Chennai, India

    Contribute to the completion of project milestones and organize own work to meet project task deadlines. · - Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs. · - Responsible for the preparation and finalizatio ...

  • Pfizer

    Associate Ii

    1 week ago


    Pfizer Chennai, India

    Functions as Regulatory support for assigned projects and the life-cycle changes; works with Project Leads/Product Leads, cross-funcational teams, local and regional regulatory colleagues, external partners (in-licensed products) and Global Health Authorities (if required) to ind ...

  • Pfizer

    Associate Ii

    2 days ago


    Pfizer Chennai, Tamil Nadu, India

    Manages day-to-day regulatory activities associated with assigned Renewals within agreed upon timelines under the guidance of Team Lead / designee. · Has fundamental knowledge of the principles and concepts of process been followed, the activities which includes but not limited t ...

  • Pfizer

    Associate Ii, Cdm

    1 week ago


    Pfizer Chennai, India

    Why Patients Need You · We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attentio ...

  • Pfizer

    Associate Ii

    8 hours ago


    Pfizer Chennai, India

    Manages day-to-day regulatory activities associated with assigned Renewals within agreed upon timelines under the guidance of Team Lead / designee. · Has fundamental knowledge of the principles and concepts of process been followed, the activities which includes but not limited t ...

  • Pfizer

    Rapd Associate I

    6 days ago


    Pfizer Chennai, India

    Qualifications · Must-Have · - Bachelor's Degree · - Proven ability to manage complex regulatory or drug development issues · - Knowledge of the regulations and guidelines in the various markets · - Strong relationship with the local health agency and other relevant stakeholders ...

  • Pfizer

    Rapd Associate I

    6 days ago


    Pfizer Chennai, India

    Qualifications · Must-Have · - Bachelor's Degree · - Proven ability to manage complex regulatory or drug development issues · - Knowledge of the regulations and guidelines in the various markets · - Strong relationship with the local health agency and other relevant stakeholders ...

  • Pfizer

    Associate I

    1 week ago


    Pfizer Chennai, India

    Why Patients Need You · We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attentio ...

  • Pfizer

    Associate Ii

    8 hours ago


    Pfizer Chennai, India

    Role Summary: · Functions as the CMC author & strategist for the Life Cycle Management (LCM) activities of assigned projects providing regulatory assessments and developing regulatory strategies for global markets including US/EU/APAC/LATAM & AfME regions; Accountable for assigne ...

  • Pfizer

    Associate I

    2 days ago


    Pfizer Chennai, India

    PROCESS IMPROVEMENT/ OPTIMIZATION INITIATIVES · - Represents India Strategy Organization for all GRA process improvement initiatives · - To work on deliverables related to optimization and efficiency in the processes and systems that are utilized within the India Strategy organiz ...

  • Pfizer

    Associate - Ii

    1 week ago


    Pfizer Chennai, India

    Manages day-to-day regulatory activities associated with assigned LEC variations within agreed upon timelines. · - Evaluate change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed. · - Performs Market Impact Assessment (M ...

  • Pfizer

    Associate Ii

    2 days ago


    Pfizer Chennai, India

    Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changes globally in collaboration with the CMC GRS.- Global regulatory strategy development in collaboration with the CMC GRS.- Liaise with Pfizer Global Supply and other support functi ...

  • Pfizer

    Associate Ii

    3 days ago


    Pfizer Chennai, India

    Manages day-to-day regulatory activities associated with assigned LEC variations within agreed upon timelines. · - Evaluate change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed. · - Performs Market Impact Assessment (M ...