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6.0 - 10.0 years
12 - 14 Lacs
bengaluru
Work from Office
Role & responsibilities The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations . The role is responsible for developing and executing regulatory strategies , managing submissions and approvals , and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management. A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485:2016 , and to ensure regulatory readiness for global markets inclu...
Posted 3 weeks ago
6.0 - 10.0 years
12 - 14 Lacs
bengaluru
Work from Office
Role & responsibilities The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations . The role is responsible for developing and executing regulatory strategies , managing submissions and approvals , and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management. A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485:2016 , and to ensure regulatory readiness for global markets inclu...
Posted 1 month ago
10.0 - 20.0 years
10 - 20 Lacs
bengaluru
Work from Office
Position Title: Regulatory Affairs & QA Manager Department: Quality & Regulatory Affairs Location: Bangalore Role Overview The Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485, MDR, US FDA, and other relevant standards. This role is critical in bridging product development, regulatory submissions, audits, and market access, ensuring patient safety and product quality at all times. Key Responsibilities Regulatory Affairs: Develop and implement regulatory strategies for product registration, approvals, and cert...
Posted 3 months ago
0.0 - 2.0 years
2 - 3 Lacs
Hyderabad
Work from Office
Roles and Responsibilities Assist in Liaise with government agencies such as State Drug Control Board, Food & Drug Administration (FDA), Central Drugs Standard Control Organization (CDSCO), and other relevant authorities. Ensure compliance with regulatory requirements related to drug licensing, manufacturing, and distribution. Develop strong relationships with key stakeholders including government officials, industry associations, and trade bodies. Provide technical support on pharmaceutical matters to internal teams and external partners.
Posted 6 months ago
3.0 - 6.0 years
2 - 5 Lacs
Hyderabad
Work from Office
Roles and Responsibilities Liaise with government agencies, including State Drug Control Organization (SDCO), Excise Department, Police Department, and other stakeholders to obtain necessary licenses and permissions for the company's operations. Ensure compliance with relevant laws and regulations related to drug control, excise, and other relevant fields. Develop strong relationships with key officials at these organizations to facilitate smooth communication and collaboration. Provide guidance on regulatory requirements to internal teams and ensure that all activities are aligned with applicable laws and regulations. Monitor developments in government policies and initiatives affecting the...
Posted 6 months ago
2.0 - 6.0 years
2 - 3 Lacs
New Delhi, Gurugram, Delhi / NCR
Work from Office
We currently looking for Medical Device Affairs and Compliance Specialist for one of our entity Faith Innovations. please find the following Job Description. 1. Designation:- Compliance Specialist ( Male only ) Salary:- 25K -35K/PM Location:- Delhi Company:- Faith Innovations No. of positions 01 Educational Qualification: B. Tech (Electrical & Mechanical engineering) Experience: Mandatory: 2-3 yr in the medical devices QA/RA Drive completion of compliance requirements whenever assigned by the Compliance team and/ or Function head i.e., to update and review records and documents for completeness and compliance as per MDR and ISO requirements Ability to understand the classification of medical...
Posted 6 months ago
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