3 Regulatory Dossiers Jobs

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2.0 - 4.0 years

0 Lacs

pune, maharashtra, india

On-site

Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following: Job Description Keeps abreast of medical device regulatory procedures, medical device safety standards and changes in global regulations. Strong working knowledge of FDA regulations, UK, EU, ISO13485, Brazil, Australia, China, Japan, Canada, and Rest of World Compiles all materials required in submissions, license renewal and annual regist...

Posted 2 weeks ago

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10.0 - 12.0 years

0 Lacs

india

On-site

Job Profile: Regulatory Affairs Manager Experience: 10+ years Location: Delhi NCR Industry: Medical Device/ Pharma Job Description: Regulatory Affairs & Quality Compliance (MDR 2017) End-to-end management of regulatory dossiers, licensing, renewals, labeling compliance, and post-market surveillance. Cross-Functional Coordination Ensures product lifecycle compliance, including change control and audit readiness. Issue & Risk Management Leads regulatory audits, manages non-compliance, and drives quick resolution of critical issues. Government Liaison Strong engagement with regulatory authorities, ministries, NPPA, CPCB, DOP, BIS, and Materiovigilance. Policy & Advocacy Tracks regulatory develo...

Posted 1 month ago

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0.0 years

0 Lacs

ahmedabad, gujarat, india

On-site

This is where your work makes a difference. At Baxter, we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. He...

Posted 1 month ago

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