Medical Device Regulatory Compliance Expert

1 day ago

Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 35,00,000
Executive Regulatory Compliance Specialist

We are seeking a highly skilled professional to spearhead regulatory compliance for our medical device clients.

  • Key Responsibilities:
  • Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
  • Collaborate with regulatory bodies for obtaining necessary permits 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 approval.
  • Implement Corrective and Preventive Actions (CAPA) to maintain compliance and drive 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.

The ideal candidate will possess a strong understanding of quality systems and regulatory frameworks for medical devices. Hands-on experience with regulatory submissions, PMS, and risk management is also essential. Additionally, excellent knowledge of GMP, GDP, and ISO 13485 standards is required. Strong communication, documentation, and coordination skills are necessary to ensure success in this role.

  • Senior Manager Regulatory Affairs

    6 days ago

    Ahmedabad, Gujarat, India beBeeRegulatoryAffairsManager Full time ₹ 9,00,000 - ₹ 12,00,000

    Key Responsibilities:\Develop Regulatory Strategy: Design, implement, and maintain a comprehensive regulatory compliance strategy to meet global market requirements for products.\Ensure Alignment with Business Goals: Develop and execute plans to align the company's overall business strategy with regulatory objectives.\Lead Global Regulatory Planning:...

  • Senior Medical Devices Specialist

    4 days ago

    Ahmedabad, Gujarat, India beBeeMedicalDevices Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Opportunity:">We are seeking a seasoned professional to fill the role of Medical Devices Assessor/Auditor.The ideal candidate will have extensive experience in quality management and medical devices, with a focus on ensuring compliance with regulatory requirements.Main Responsibilities:Audit and assess medical devices to ensure adherence to regulatory...

  • Regulatory Affairs Specialist

    2 weeks ago

    Ahmedabad, Gujarat, India Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a...

  • Senior Regulatory Compliance Specialist

    2 days ago

    Ahmedabad, Gujarat, India beBeeRegulatory Full time US$ 80,000 - US$ 1,20,000

    Job Title: Regulatory Affairs SpecialistJob Description:We are seeking an experienced candidate to join our dynamic team in the Quality Assurance / Regulatory affairs, in the field of class III / class D Medical devices Certification, QMS Quality Assurance, Regulatory Compliances.The successful candidate will be responsible for leading new product...

  • Leading Regulatory Compliance Initiatives

    17 hours ago

    Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 21,00,000

    We are seeking a highly skilled and experienced Regulatory Affairs Specialist to lead our regulatory compliance initiatives.As a key member of our team, you will be responsible for ensuring that our medical devices meet all relevant regulatory requirements, both in India and internationally. This includes developing and implementing comprehensive regulatory...

  • Innovative Medical Device Designer

    2 days ago

    Ahmedabad, Gujarat, India beBeeMechanical Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Title: Mechanical Design ArchitectOverviewWe are seeking a highly skilled Mechanical Design Architect to lead the development of innovative medical devices. The ideal candidate will have a strong background in mechanical engineering and design, with expertise in CAD software and FEA simulation tools.Key ResponsibilitiesConceptualize, design, develop, and...

  • Regulatory Affairs Leader

    3 days ago

    Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 1,75,00,000 - ₹ 2,25,00,000

    Regulatory Affairs LeaderAbout the RoleWe are seeking a skilled Regulatory Affairs professional to lead our team and drive strategic growth in the medical devices industry.Key Responsibilities:Develop and implement a comprehensive regulatory compliance strategy to meet global market requirements for our products.Collaborate with cross-functional teams to...

  • Senior Manager Regulatory Affairs

    6 days ago

    Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full time

    Designation: Regulatory Affairs ManagerIndustry: Medical Devices (Orthopedic devices preferred)Experience required: 10 to 15 YearsLocation: Sanand, AhmedabadCompany overview:A globally‑recognized orthopedic medical device firm founded in 2003, delivering cutting-edge sports‑medicine and extremities implants and instruments across six continentsDriven by...

  • Regulatory Affairs Director

    4 days ago

    Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 30,00,000 - ₹ 40,00,000

    Job Title: Senior Manager Regulatory AffairsAbout the Role:We are seeking a seasoned senior manager to lead our regulatory affairs team and spearhead compliance strategy for global markets.Key Responsibilities:Compliance Strategy Development: Develop and implement comprehensive regulatory compliance strategies tailored to meet global market...

  • Medical Device MES Systems Expert

    2 days ago

    Ahmedabad, Gujarat, India beBeeImplementation Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

    Job Title: Siemens Opcenter MES Implementation SpecialistWe are seeking a highly skilled professional to implement and upgrade Opcenter Execution Medical Device and Diagnostics systems.Install and upgrade component software for Opcenter Execution Medical Device and Diagnostics systems.Configure interfaces using Opcenter Connect MOM, including OPC UA for...