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 ensuring compliance with medical device regulations and quality standards. Your key responsibilities will include: - Stay updated on medical device regulations, standards, and guidelines such as FDA, ISO, and CE Marking to ensure product compliance. - Develop and implement quality assurance processes and procedures to maintain product quality. - Conduct internal audits and assessments to identify areas for improvement. - Collaborate with production teams to establish quality control measures. - Maintain and organize regulatory and quality documentation for filing and submissions. - Coordinate and particip...

Posted 3 days ago

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Clinical Research Scientist (Device, Ortho) Jupiter Life Science Consulting

4.0 - 8.0 years

0 Lacs

maharashtra

On-site

As a Clinical Research Scientist at Red Nucleus, you will play a crucial role in developing post-market clinical research strategies for orthopedic devices to meet global regulatory and post-market surveillance requirements. Your responsibilities will include: - Collaborating with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to devise post-market clinical evidence generation strategies aligned with EU Medical Device Regulations (EU MDR). You will facilitate clinical evidence reviews, document decisions and risks, and craft PMCF Plans. - Independently developing and crafting high-quality Post-market Clinical Follow-up (PMCF) plans and reports. You will also assist in...

Posted 1 month ago

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Regulatory Associate- Biosimilar combination product Dr. Reddy's Laboratories

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

Role Overview: You will be a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations). Your primary responsibility will involve developing and executing global regulatory strategies for combination product devices. Your focus will be on ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. Key Responsibilities: - Provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. - Lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. - E...

Posted 2 months ago

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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 Do...

Posted 3 months 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 manufa...

Posted 3 months ago

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