Manager - Quality Assurance La-med Healthcare

6.0 - 10.0 years

0 Lacs

faridabad, haryana

On-site

As a Regulatory Affairs and Quality Assurance professional, you will be responsible for staying updated on medical device regulations, standards, and guidelines from organizations such as FDA, ISO, and CE Marking. Your role will involve ensuring that products meet all regulatory requirements and maintaining relevant documentation. In the realm of Quality Assurance, you will be tasked with developing and implementing quality assurance processes and procedures. This will include conducting internal audits and assessments to identify areas for improvement. Additionally, you will collaborate with production teams to establish quality control measures. Your responsibilities will also encompass Documentation Management, where you will maintain and organize regulatory and quality documentation. You will be expected to prepare and submit regulatory filings like 510(k) submissions or CE Mark applications, as well as create and update technical files and product documentation. As part of Compliance Audits, you will coordinate and participate in regulatory audits and inspections. Addressing findings and implementing corrective and preventive actions (CAPA) as needed will be crucial to ensuring compliance. In the domain of Risk Management, you will access and manage product risks in alignment with applicable standards. Developing and maintaining risk management files and reports will be essential in this capacity. Your role will involve Cross-Functional Collaboration with R&D, manufacturing, and clinical teams to ensure alignment with quality and regulatory requirements. You will provide regulatory guidance during product development and changes to ensure compliance. Furthermore, in Post-Market Surveillance, you will be responsible for monitoring and reporting adverse events or non-compliance issues. To excel in this role, you should hold a Bachelor's degree in a Science field, B.Pharma/M.Pharma, Biomedical Engineering, or a Diploma in Regulatory Affairs or Quality Management System. A minimum of 6 years of experience in Quality Assurance and Regulatory Affairs is required, along with knowledge of medical device regulations and quality standards such as FDA 21 CFR Part 820 and ISO 13485.,

Posted 1 day ago

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Regulatory Associate Dr. Reddy's Laboratories

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufacturing considerations. You will lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. Accuracy in regulatory documentation for design control, risk assessment, usability studies, and post-market surveillance will be critical in this position. Collaboration with R&D, Quality, Clinical, and Manufacturing teams is essential to align regulatory strategies with product development. You will also support design verification and validation activities, including human factors engineering (HFE) and risk management. Your role will involve providing regulatory support for product lifecycle management, including manufacturing changes, labeling updates, and device modifications. By leveraging your expertise in regulatory affairs, you will contribute significantly to the success of regulatory processes for biosimilar combination products.,

Posted 1 week ago

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