Director quality regulatory affairs
3 weeks ago
About Qure. AI: Qure. AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted over 22 million patients in more than 90 countries worldwide. At Qure.ai, we are committed to fostering a diverse and inclusive workplace where talent thrives. About the Job Job Title: Director – Quality & Regulatory Affairs Job Description: The Director of Quality & Regulatory Affairs will serve as the primary liaison for quality system management and regulatory affairs, interfacing with external (regulatory agencies, customers) and internal stakeholders. This role is ideal for someone with deep knowledge of AI regulations, Software as a Medical Device (Sa MD), and global regulatory frameworks, especially FDA, EU MDR, cybersecurity, and quality standards. This individual will lead a team of specialists, coordinate cross-functional deliverables, and guide product approvals and compliance across global markets. Roles and Responsibilities: Regulatory Affairs & Compliance Leadership: Act as the main regulatory liaison with global regulatory agencies for pre-submissions, submissions, and post-market activities. Lead and oversee the development of regulatory pathways, including clinical study design and regulator negotiations. Remain current with evolving regulations (FDA, EU MDR, ISO 13485, IEC 62304, ISO 14971) and advise on strategic implications. Quality Management System (QMS) Oversight: Ensure adherence to QMS policies and regulatory standards, including ISO 13485 and FDA guidelines. Manage internal and external audits, including preparation, resolution of findings, and coordination with auditing groups. Oversee documentation for Corrective and Preventative Actions (CAPA) and ensure it is communicated with all stakeholders. Cross-functional Collaboration & Strategy: Coordinate cross-functional activities to support product development, approval, and strategic planning. Partner with internal teams to execute regulatory strategies for global market entry and compliance. Act as a regulatory affairs advisor, guiding research directions and influencing strategic decisions. Product Validation & Compliance: Develop and review validation documentation for Sa MD and CAD devices to ensure regulatory compliance. Review product labeling, marketing materials, and customer statements for compliance and make recommendations. Regulatory Documentation & Monitoring: Assist in the preparation and submission of 510(k) filings. Conduct regulatory monitoring activities to identify and respond to new or revised requirements, performing regulatory gap analyses. What Does Success Look Like: Success in this role includes ensuring that our products meet or exceed regulatory compliance standards, that cross-functional teams are aligned with regulatory requirements throughout product lifecycles, and that regulatory pathways are efficiently navigated to support timely market entry and sustainable compliance. Skills and Expertise: Proven experience in a senior regulatory role within an AI medical device company. Extensive knowledge of FDA and EU MDR requirements, QMS, and medical device regulations. Master’s degree (technical discipline preferred); RAC certification is a plus. Strategic thinking with the ability to align regulatory needs with portfolio opportunities. Strong project management and multitasking skills in cross-functional environments. Exceptional written and verbal communication skills for clear documentation, presentations, and team discussions. Demonstrated commitment to quality and continuous improvement, with a proactive approach to regulatory challenges. At Qure.ai: You will be part of a rapidly growing organization, with an opportunity to work alongside the best minds in the industry. Competitive compensation and rewards, along with the chance to grow with a young company. Inclusive Workspace: By submitting your information and application, you confirm that you have read and agree to the Applicant Privacy Policy .
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Director quality regulatory affairs
3 weeks ago
Mumbai, India Qure.ai Full timeAbout Qure. AI:Qure. AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted over 22...
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Director Quality Regulatory Affairs
3 weeks ago
Mumbai, India Qure.ai Full timeAbout Qure.AI: Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted over 22...
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Director Quality Regulatory Affairs
3 weeks ago
Mumbai, India Qure.ai Full timeAbout Qure.AI:Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted over 22...
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mumbai, India Qure.ai Full timeAbout Qure.AI:Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted over 22...
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▷ [15h Left] Director Quality Regulatory Affairs
2 weeks ago
Mumbai, India Qure.ai Full timeAbout Qure.AI:Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted over 22...
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mumbai, India Qure.ai Full timeAbout Qure.AI: Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted over 22...
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Regulatory Affairs Director
1 week ago
Mumbai, Maharashtra, India Lifelancer Full timeAbout LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.Salary InformationThe estimated annual salary for this role is ₹1,500,000 - ₹2,250,000.Job DescriptionThis experienced professional will work under limited supervision to apply subject matter knowledge in the area of Regulatory Affairs.Direct development of product...
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Regulatory Affairs Director
1 week ago
Navi Mumbai, Maharashtra, India Domnic Lewis International Full timeWe are seeking a seasoned professional to join Domnic Lewis International as our Regulatory Affairs Director.About the Role:Develop and implement regulatory strategies to ensure compliance with international regulations.Collaborate with cross-functional teams to gather inputs necessary for regulatory submissions.Maintain plant compliance with regulatory...
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Vacancy for Regulatory Affairs at Delhi Ncr
6 months ago
Mumbai, India RIGHT STAFF Full timeGreetings from Right Staff One of our client who are into Medical Devices Are looking for a Regulatory Affairs person at Delhi NCR Job Description - Designation - Regulatory Affairs/QA Affairs Time - Day Shift Location - Delhi NCR **Responsibilities**: - 1. Identify regulatory and post market requirements for new products or product enhancements early...
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Regulatory Affairs Director
4 weeks ago
Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeJob Description:Career Opportunities at 1925 GlaxoSmithKline LLCThis is an exceptional opportunity to join our team as a Regulatory Affairs Director in Pharmaceutical Development. We are seeking an experienced professional to lead the development of global regulatory strategies for pharmaceutical products.Job Summary:The successful candidate will be...
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Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeAt 1925 GlaxoSmithKline LLC, we are seeking an experienced Regulatory Affairs Director to join our team. This role offers a competitive salary of $180,000 per annum.This position is responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams...
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Mumbai, India Abbott Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. Abbott...
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Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer in Mumbai, India. As a key member of our Regulatory Operations department, you will be responsible for ensuring compliance with regulatory requirements across various product categories.The ideal candidate will have a BS degree in Pharmacy or Life Sciences and 1+...
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Regulatory Affairs Officer
4 months ago
Mumbai, Maharashtra, India TheTalentforte.com Full timeManufacturer of Bio-Pharmaceuticals, Soft Gel Capsules & Multi-Vitamins **REGULATORY AFFAIRS** Job Location: Borivali West **Experience: Min. 2 years in Pharma Formulations** - Conduct quality assurance activities to ensure compliance with regulatory requirements. - Manage regulatory audits by providing necessary documentation and support. - Maintain...
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Regulatory Affairs Executive
4 weeks ago
mumbai, India Ipca Laboratories Limited Full timePosition : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.PharmExperience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:Preparation of registration dossiers as per the US Regulatory guidelinesPreparation of renewal application as...
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Regulatory Affairs Executive
6 months ago
Mumbai, India Morpheus Human Consulting Full timeReference Code: - 319-58 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Job Title: Regulatory Affairs Executive - Vile Parle - Mumbai - **Job Description**: - Managing regulatory affairs of the organization & its subsidiaries / associates. - Liaising with regulatory bodies like...
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Regulatory Affairs Executive
4 weeks ago
mumbai, India Ipca Laboratories Limited Full timePosition : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.PharmExperience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:- Preparation of registration dossiers as per the US Regulatory guidelines- Preparation of renewal application as...
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Regulatory Affairs Executive
4 weeks ago
mumbai, India Ipca Laboratories Limited Full timePosition : Executive - Regulatory affairs formulation for USA market. Qualification : B.Pharm/M.Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred. Role: - Preparation of registration dossiers as per the US Regulatory guidelines - Preparation of renewal...
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Regulatory affairs executive
2 months ago
Mumbai, India Ipca Laboratories Limited Full timePosition : Executive - Regulatory affairs formulation for USA market. Qualification : B. Pharm/M. Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred. Role: Preparation of registration dossiers as per the US Regulatory guidelines Preparation of...
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Associate, Regulatory Affairs
1 month ago
Mumbai, Maharashtra, India Colgate-Palmolive Full timeRelocation Assistance Offered Within Country Job Number #163733 - Mumbai, Maharashtra, India **Who We Are** Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the...
