
Senior Medical Device Regulatory Specialist
3 days ago
We are seeking an experienced Senior Regulatory Specialist to join our team.
Job Description:
The ideal candidate will have a strong understanding of quality systems and regulatory frameworks for medical devices, with hands-on experience in regulatory submissions, post-market surveillance, and risk management.
Key Responsibilities:
- Ensure compliance with regulatory requirements, including ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
- Coordinate with regulatory authorities, such as FDA and CDSCO, for obtaining necessary permissions and approvals.
- Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and III medical devices.
- Manage regulatory submissions and ensure timely approvals.
- Handle corrective actions to maintain compliance and continuous improvement.
- Support audits, inspections, and ensure readiness for regulatory authority reviews.
Candidate Profile:
- Strong understanding of quality systems and regulatory frameworks for medical devices.
- Hands-on experience with regulatory submissions, PMS, and risk management.
- Excellent knowledge of GMP, GDP, and ISO 13485 standards.
- Strong communication, documentation, and coordination skills.
About the Role:
This is a challenging opportunity for a skilled regulatory professional to make a real impact in the medical device industry. If you have a passion for ensuring patient safety and product integrity, we encourage you to apply.
-
Lead Medical Device Hardware Engineer
3 days ago
Agra, Uttar Pradesh, India beBeeHardware Full time ₹ 20,00,000 - ₹ 25,00,000Medical Device Hardware SpecialistOur organization is dedicated to designing and developing cutting-edge medical devices. We are seeking a skilled Medical Device Hardware Specialist to join our team.As a Medical Device Hardware Specialist, you will be responsible for the design, development, and testing of medical device hardware. This includes designing...
-
Agra, Uttar Pradesh, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000Senior Medical Device Engineer PositionWe are seeking a seasoned medical device engineer to fill this key role.About the Role:Oversee the assessment and auditing of medical devices to ensure compliance with regulatory standards.Key Responsibilities:Assess and audit medical devices to verify they meet regulatory requirements.Collaborate with cross-functional...
-
Medical Device Innovation Specialist
4 days ago
Agra, Uttar Pradesh, India beBeeMedtech Full time ₹ 15,00,000 - ₹ 25,00,000Medical Device Innovation SpecialistWe are seeking a highly skilled professional to join our team in driving innovation and excellence in medical device development.Create a Quality culture by driving compliance activities around a specific product, site or region.Experience in Medical Device QMS processes.Has ability to organize, drive rigorous compliance...
-
Senior Regulatory Specialist
4 days ago
Agra, Uttar Pradesh, India beBeeRegulatory Full time ₹ 2,50,00,000 - ₹ 3,50,00,000Senior Regulatory SpecialistWe are seeking an exceptional Senior Regulatory Specialist to join our team in Mumbai.The ideal candidate will have a strong background in financial regulation, risk management, and compliance. They will be responsible for steering complex client engagements across regulatory supervision, policy formulation, risk management, and...
-
Medical Devices Technician
3 days ago
Agra, Uttar Pradesh, India beBeeMedicalDevices Full time ₹ 6,00,000 - ₹ 14,00,000Job OpportunityA Medical Devices Technician is responsible for ensuring medical equipment safety, accuracy, and proper functioning.Main ResponsibilitiesInspect, calibrate, maintain, and repair complex medical devices used in patient care.Perform routine and advanced troubleshooting to guarantee equipment reliability and accurate diagnosis/treatment...
-
Chief Regulatory Compliance Officer
4 days ago
Agra, Uttar Pradesh, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,20,00,000Regulatory Affairs ProfessionalWe are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO...
-
Senior Regulatory Affairs Expert
4 days ago
Agra, Uttar Pradesh, India beBeeRegulatoryAffairs Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Regulatory Affairs Specialist Role OverviewOur organization seeks an experienced Senior Regulatory Affairs Specialist to lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.The successful candidate will oversee compilation and submission of Annual Reports, amendments, and deficiency responses,...
-
Medical Content Specialist
7 days ago
Agra, Uttar Pradesh, India beBeeEditing Full time ₹ 12,00,000 - ₹ 15,00,000Medical Content Specialist">We are seeking a highly skilled Medical Editor who will be responsible for reviewing, editing and ensuring the quality and accuracy of medical and scientific documents. This role involves working closely with medical writers and subject matter experts to produce clear, consistent and compliant content for publication or regulatory...
-
Medical Equipment Procurement Specialist
4 days ago
Agra, Uttar Pradesh, India beBeeProcurement Full time ₹ 15,00,000 - ₹ 20,00,000Job Title: Senior AssociateWe are seeking a highly skilled professional to oversee the end-to-end procurement process of medical equipment, from market research and supplier negotiations to ensuring regulatory compliance and vendor management.Negotiate with suppliers to secure favorable terms, pricing, and service agreements.Manage vendor relationships and...
-
Regulatory Compliance Specialist
4 days ago
Agra, Uttar Pradesh, India beBeeCompliance Full time ₹ 9,00,000 - ₹ 18,00,000Regulatory Compliance Specialist Job Overview: The Regulatory Compliance Specialist will be responsible for ensuring timely adherence to regulatory and statutory requirements. Key Responsibilities: Conduct comprehensive AML transaction monitoring and risk categorization of customers Collaborate with various departments on compliance review and monitoring...