Career

Experience: 0 – 5 Yrs.

Qualification: MS-Regulatory affairs, Diploma in Regulatory Affairs, M Pharmacy, B.E Biomedical engineering, M.sc Biotechnology, M.sc Microbiology & graduation/post-graduation in any related scientific discipline

Job Profile: As a Regulatory Affairs executive, you shall:

• Prepare technical documentation for various national (Indian MDR) and international regulations (CE, USFDA, UKCA, Country registrations) applicable to a wide range of medical devices on project basis.
• Clinical evaluation writing
• Gap analysis of client documentation and recommendation/working on changes
• Communication with client on routine basis for project related information and data
• Collect, review and integrate data in regulatory submissions.
• Advise manufacturers on regulatory requirements when needed
• Visit to Project site for understanding manufacturer’s practices to be integrated in the technical documentation
• Attend to client queries, doubts and review comments
• Audit client premises when required and also supporting client for certification audits
• Departmental activities, discussions and research for continual improvement
• Keep up with updates in standards, guidelines and other regulatory requirements
• Where needed support in preparation of training material and conducting training for various in-house, open-house, online and customized trainings requested by clients.

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Experience: 0 – 5 Yrs.

Qualification: MS-Regulatory affairs, Diploma in Regulatory Affairs, M Pharmacy, B.E Biomedical engineering, M.sc Biotechnology, M.sc Microbiology & graduation/post-graduation in any related scientific discipline

Skills: Excellent communication, verbal, and writing skills, excellent planning, organization, and flexibility to adjust to a rapidly changing environment, strong attention to detail, ability to work independently and in a team environment, Proficient in Microsoft Excel, Word.

Job Profile: As a Quality Assurance Executive, you shall:

Quality Management System:

• Prepare quality management system documentation as per standard requirements of ISO 9001, ISO 13485, 21 CFR Part 820, MDSAP, Integrated quality management system based on combination of aforementioned
• Gap analysis of existing QMS documentation and recommendation/working on changes
• Implementation of QMS within the clients’ premises and training employees in clients’ organization on how to adequately fill the formats and retain them
• Communicate with client on routine basis for project related information and data
• Collect, review and integrate data in documentation
• Visit to Project site for understanding manufacturer’s practices to be integrated in the technical documentation and for implementation
• Attend to client queries, doubts and review comments
• Conduct initial Internal Quality Audit and Management Review Meeting at client premises and also support client for certification audits
• Departmental activities, discussions and research for continual improvement
• Keeping up with updates in standards, guidelines and other regulatory requirements
• Where needed support in preparation of training material and conducting training for various in-house, open-house, online and customized trainings requested by clients.
• Shall have basic knowledge of technical documentation of EU-MDR including risk management, clinical evaluation, post market surveillance.
• Plans, organizes, and coordinates validation activities at the facilities. Write validation protocols and compile final reports.

Experience: 0 – 5 Yrs.

Qualification: MS-Regulatory affairs, Diploma in Regulatory Affairs, M Pharmacy, B.E Biomedical engineering, M.sc Biotechnology, M.sc Microbiology & graduation/post-graduation in any related scientific discipline

Job Profile: As a Contract Management – Executive, you shall:

• Support implementation, development, maintenance and control of a quality management system according to international standards and corporate guidelines/policies/procedures and applicable regulations for certification held by the client
• Prepare annual AMC calendar under the supervision of department head
• Conduct Internal Quality Audit and Management Review Meeting at intervals defined in QMS of the client
• Prepare and Support client for re-certification and surveillance audits
• Ensure closure of non-conformities observed during such audits, verify implementation of such corrective actions, and maintain relevant evidence.
• Maintaining clients technical documentation, assure an effective, consistent and reliable forward of information in terms of product surveillance
• Visit client premises at frequency defined in the AMC calendar, support their routine activities, and provide appropriate guidance
• Prepare monthly follow ups for Post market data and monthly status report with details of all activities performed for a specific AMC client
• Prepare PMSR, PSUR, PMCF report, Analysis of data, on annual basis based on the data received from the client
• Update MAUDE, MHRA and information retrieved from other databases along with Sales, complaint and audit data in the Clinical evaluation on annual basis
• Update risk if any new hazards or hazardous situation are identified during routine production and post production activities
• Review customer feedbacks, customer complaints, distributor agreements, supplier evaluation and re-evaluation, training records, quality objectives routine batch manufacturing records, calibration records, and preventive maintenance schedule.
• Verify Corrective Action Reports against customer complaints and Internal Quality Audit.
• Continuous communication with the client to address their concerns w.r.t scope of AMC

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