Senior Clinical Affairs Analyst

5 days ago


Bengaluru, Karnataka, India Siemens Healthineers Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job ID

476897

Posted since

23-Sep-2025

Organization

Siemens Healthineers

Field of work

Clinical

Company

Siemens Healthcare Private Limited

Experience level

Experienced Professional

Job type

Full-time

Work mode

Office/Site only

Employment type

Permanent

Location(s)

  • Bangalore - Karnataka - India

Position Summary:

We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CER's that support the applicable regulatory submission requirements for the medical device products.

An experienced Clinical Analyst professional has relevant medical/life-science qualification and knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 7 - 8 years with a minimum of 3 – 4 years of CER writing experience is essential. A minimum of 3 – 4 years of medical writing/reviewing experience is needed. The experience is expected to be current or recent (preferably within the past two years), to provide confidence in their experience considering the rapid nature of updates/changes in the regulatory landscape, the device, its functionalities and the therapy area.

Preferred Education: Masters' degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience

Preferred Experience:

  1. The expected experience is 7 – 8 years with minimum 3 – 4 years of CER writing and reviewing experience as per EU MDR (European Union Medical Device Regulation (EU) 2017/745). Significant experience writing scientific, medical/clinical, and technical content. Also, a plus would be experience with writing CERs that conform to MEDDEV 2.7/1.

  2. Knowledge in the therapeutic area – specifically in the field of diagnostic radiology, interventional radiology and radiation oncology

  3. Familiarity with various country specific standards and regulations for medical devices to be able to assess and provide device appropriate clinical evaluation data for registrations.



  • Bengaluru, Karnataka, India Siemens Healthineers Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job ID479585Posted since17-Oct-2025OrganizationSiemens HealthineersField of workQuality ManagementCompanySiemens Healthcare Private LimitedExperience levelExperienced ProfessionalJob typeFull-timeWork modeOffice/Site onlyEmployment typePermanentLocation(s)Bangalore - Karnataka - IndiaWe are looking to add an experienced Clinical Writer to our team. The...


  • Bengaluru, Karnataka, India MS CLINICAL RESEARCH Full time ₹ 8,00,000 - ₹ 24,00,000 per year

    Job Title:Senior Clinical Research Associate (Sr. CRA)Company:MS Clinical Research Pvt LtdExperience:Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...


  • Bengaluru, Karnataka, India, Karnataka MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...


  • Bengaluru, Karnataka, India Alcon Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Supports Clinical Development, Clinical Operations, Clinical Evaluations, MedicalAffairs and Medical Safety including Post Market Surveillance activities for all Alconfranchises, to maximize standardization and compliance. Informs senior management of the need for corrective and preventive actions with akey advisory role in the development of action plans...


  • Bengaluru, Karnataka, India IQVIA Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Regulatory Affairs Officer Job Overview Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions • Acts as a Regulatory Team Member on...

  • Reg Affair Officer

    1 day ago


    Bengaluru, Karnataka, India IQVIA Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role Summary:We are seeking a qualified Regulatory Affairs Project Coordinator and manage outsourced local regulatory affairs activities across multiple international markets. The role involves coordinating regulatory submissions, artwork workflows, database updates, and compliance tracking, ensuring alignment with global standards and internal SOPs.Key...


  • Bengaluru, Karnataka, India Emerald Clinical Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    At Emerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from...


  • Bengaluru, Karnataka, India Precision for Medicine Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Position Summary: The Senior Manager, Clinical Data Engineering manages the day-to-day activities of the Clinical Data Engineering function in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study specific plans with an emphasis on effective resourcing and development of personnel. Provides oversight for data engineering...


  • Bengaluru, Karnataka, India Avance Clinical Full time ₹ 1,50,000 - ₹ 28,00,000 per year

    Core ResponsibilitiesDevelop, manage, and optimize visualizations, dashboards, and reporting tools to support clinical and business operations.Collaborate with cross-functional teams to deliver actionable insights that improve decision-making and operational efficiency.Perform data analysis, modeling, and reporting, utilizing tools like Spotfire, Python, and...


  • Bengaluru, Karnataka, India Infosys Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Regulatory and Clinical Business AnalystAbility to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability • Good knowledge on software configuration management systems • Awareness of latest technologies and Industry trends • Logical thinking and problem solving skills along...