Regulatory Affairs Analyst
20 hours ago
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 registrations to FDA, Health Canada, China NMPA, and other international authorities. Supports global product registrations, including the compilation and maintenance of regulatory dossiers, technical documentation, and country-specific submission materials. Performs device classification assessments in accordance with regulatory frameworks in the U.S., Canada, EU, China, and other global markets Maintains strong understanding of country-specific documentation and regulatory expectations for product submissions, compliance, and import/export. Prepares and provides Certificates of Compliance, Declarations of Conformity, and other supporting compliance documents for internal and external stakeholders. Participates in post-market surveillance, GMP compliance, 3rd party audits, inspections, reviews and approves advertising and promotions materials. Recommends changes for labeling, manufacturing, marketing, and usability protocols for medical device regulatory compliance. Participate as team member to plan, develop, and implement regulatory strategy throughout the medical device product lifecycle. Reviews and approves design outputs. Uses regulatory information and knowledge to integrate regulatory perspectives into the organization, its policies, and procedures. Reviews, approves, and recommends changes for labeling, manufacturing, marketing, and test protocols for regulatory compliance and/or approval. Required Skills and Experiences Bachelor’s Degree in life sciences, engineering, regulatory compliance, 2+ years of experience in regulatory compliance in the medical device industry and medical device safety standards. 2+ years of experience driving related medical device safety standards into design requirements. 2+ years of experience completing multiple submissions across health authorities. Experience with Class I, II, and/or III medical devices and industrial products (including experience determining device classifications globally). Proven track record of preparing and managing regulatory submissions (e.g., FDA 510(k), Health Canada License Applications, EU Technical Files, NMPA dossiers, etc.). Experience supporting product registrations and certifications across multiple international markets. Microsoft Office/ERP/QMS Software competency What we offer A unique opportunity to become part of growing organization in India being part of a global market leader in Xray imaging components. Excellent development potential An international work environment with global teams collaborating on various projects across several countries. Competitive compensation package including participation in Varex incentive plans Corporate Health Benefits Additional benefits will be added as we grow
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Regulatory Affairs Executive
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Delhi, Delhi, India SAVVI SALES AND SERVICE PVT.LTD. Full timeJob Title: Regulatory Affairs Executive Location: Rohini, Delhi Industry: Pharmaceuticals / Nutraceuticals Salary Package: ₹25,000 - ₹50,000 per month Gender Preference: Male Experience Required: 2-3 years in Pharma or Nutra Industry (Regulatory Affairs) Key Responsibilities: - Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs,...
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Regulatory Affairs Director
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delhi, India beBeeRegulatoryAffairs Full timeRegulatory Affairs ProfessionalWe are seeking a highly skilled and experienced professional to oversee our Regulatory Affairs department.Ensure adherence to regulatory requirements and handle government affairsLiaise with relevant authorities, including industry bodies and other stakeholdersRespond to correspondences and queries from and to regulatory...
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Regulatory Affairs Specialist
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Delhi, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Specialist
2 weeks ago
Delhi, India Concept Medical Full timeAbout Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...
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7 days ago
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Regulatory Affairs Executive
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Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full timeJob Description - **Regulatory Affairs Executive Medical Devices** As a Manager - Regulatory and Government Affairs for Medical Devices, you would be expected to actively engage with government stakeholders and regulatory bodies to ensure crisp and effective representation on regulatory and policy matters and ensure continuity of license and permits as well...
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Regulatory Affairs Associate
2 weeks ago
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Regulatory Affairs Pharmacist
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Delhi, India Gentell Full timeGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
