Regulatory Affairs Specialist Tek Support

0.0 years

0 Lacs

mumbai, maharashtra, india

Remote

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

Posted 2 weeks ago

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Hiring For Instrumentation Section Head - Baddi Samridhi

7.0 - 12.0 years

6 - 12 Lacs

Baddi

Work from Office

Role & responsibilities 1. To control and maintain distributed control system and ensure its availability to the plant. 2. To carry out computerized maintenance system connected jobs and ensure adherence to all compliances as per IMS guidelines. 3. Responsible for carrying out the breakdown review for the FIR/FAR system to adopt corrective and preventive actions after breakdowns and to determine the root cause of breakdowns. 4. To look after the manpower management of the department with emphasis on continuous development of the team members through trainings/knowledge sharing sessions. 5. To ensure regular correspondence with suppliers or partners for the development of the new system, cont...

Posted 1 month ago

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QARA Engineer Larsen & Toubro (L&T)

5.0 - 10.0 years

0 - 1 Lacs

Bengaluru

Work from Office

Job Title: QARA ENGINEER Experience: 4.5 to 10 years Location: Bangalore Mandatory Skill: US FDA, 510K, PMA, EU MDR, QARA. Regulatory gap assessment and remediation. Job Description: The objective of this project is to identify and remediate any deficiencies in the design history files (DHF) and device master records (DMR) of the stent graft integrated with 4 branched vascular prosthesis - FROZENIX 4 Branched, ensuring adherence to relevant standards, US Food and Drug Administration ("FDA") guidelines and regulations requirements by completing all necessary tasks including document translation (Japanese to English), gap assessment, remediation and submission query support. Design verificatio...

Posted 2 months ago

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D365 F&O Finance Functional Consultant Claranet Group

5.0 - 8.0 years

14 - 24 Lacs

Hyderabad

Remote

We at Claranet are looking for F&O Finance Functional Professionals who will be involved in all aspects of implementing supporting Dynamics solutions through the project life cycle to go live and ongoing support. You can contribute to Solution Design sessions, help with configuration, help with data migration deliverables, create required interface design and functional design documents, troubleshoot customization, etc. Role- D365 F&O Functional Consultant (Full Time) Office Location Hitech, Hyderabad - India Working mode : Remote Interested Candidates can your CV on Rakesh.koyya@claranet.com Key Responsibilities: Analyze business processes (Finance, PMA) to identify opportunities for improv...

Posted 3 months ago

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Urgent hiring For Instrumentation Section Head - Baddi Samridhi

7.0 - 12.0 years

6 - 12 Lacs

Baddi

Work from Office

Posted 3 months ago

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