Pharmaceutical and Medical Device Regulatory Compliance Specialist

2 days ago


Cochin, Kerala, India beBeeRegulatory Full time ₹ 16,00,000 - ₹ 20,20,000

Job Title: Regulatory Affairs Professional

We 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 13485, ICH guidelines).

Key Responsibilities:

  • Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interacted with regulatory authorities during product submissions, inspections, and audits.
  • Developed and maintained regulatory strategies to support new product development and lifecycle management.
  • Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  • Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
  • Managed regulatory documentation archives and maintained compliance records for audits and inspections.


  • Cochin, Kerala, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

    Medical Device Regulatory ExpertJob Overview:We are seeking a seasoned Medical Device Regulatory Expert to oversee compliance with stringent regulatory requirements.Key Responsibilities:Ensure strict adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.Collaborate closely with regulatory authorities for obtaining necessary permissions and...


  • Cochin, Kerala, India beBeeDevice Full time ₹ 20,00,000 - ₹ 25,00,000

    Senior Medical Device ProfessionalJob Overview:We seek a seasoned Senior Medical Device Professional to spearhead our medical devices initiative. The ideal candidate will have an extensive background in medical devices and a proven track record of assessing and auditing medical devices.10+ years of professional experience in the medical devices industry,...


  • Cochin, Kerala, India beBeeMedicalWriter Full time ₹ 20,00,000 - ₹ 25,00,000

    Job TitleWe are seeking an experienced Medical Writer to lead our content development team. This role requires a strong background in medical and scientific writing, particularly in the field of medico-marketing/marketing communications.Key Responsibilities:Create high-quality medical communication materials, including scientific manuscripts, medical...


  • Cochin, Kerala, India beBeeMedicalDevices Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Design Engineer for Medical DevicesThis is an exciting opportunity to join our team as a Design Engineer for Medical Devices. In this role, you will be responsible for conceptualizing, designing, and developing innovative mechanical systems and sub-systems for medical devices. Your primary responsibilities will include:Designing new products or components to...


  • Cochin, Kerala, India beBeeMedication Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title:Pharmacist">About the Role:The successful candidate will be responsible for preparing and dispensing medications, providing drug information and counsel to patients and healthcare professionals, ensuring proper storage and handling of pharmaceutical products, and maintaining accurate records.This includes monitoring patient drug therapies, managing...


  • Cochin, Kerala, India beBeeCompliance Full time ₹ 20,000 - ₹ 25,000

    Job OverviewThe Compliance Executive plays a pivotal role in maintaining regulatory compliance across residential child care facilities.This key position involves conducting regular audits to ensure accurate records and safeguarding practices are upheld.Close liaison with Registered Managers and senior management teams is crucial for ensuring accurate...


  • Cochin, Kerala, India beBeeValidationEngineer Full time ₹ 10,50,000 - ₹ 16,50,000

    Our team is seeking an experienced Validation Engineer to join our organization.Key responsibilities will include ensuring compliance with regulatory requirements, implementing system validation processes and performing quality audits.Mandatory Skills for the Job:5-8 years of hands-on experience in Computer System Validation/Quality Compliance in a FDA...


  • Cochin, Kerala, India beBeeCompliance Full time ₹ 17,49,098 - ₹ 25,12,085

    Regulatory Compliance Specialist Job DescriptionThis role focuses on ensuring adherence to regulatory requirements and governance processes. The successful candidate will work closely with senior leadership and board-level committees to provide compliance guidance and support.Key Responsibilities:Regulatory Monitoring & Implementation:Track and evaluate...


  • Cochin, Kerala, India beBeePharmacist Full time ₹ 15,00,000 - ₹ 20,00,000

    Pharmacists play a crucial role in ensuring the safe and effective use of medications. This is a full-time on-site role located in Kochi, requiring a professional with excellent attention to detail and strong organizational skills.The successful candidate will be responsible for preparing and dispensing medications, providing drug information and counsel to...


  • Cochin, Kerala, India beBeePharmaceutical Full time ₹ 8,00,000 - ₹ 12,00,000

    Job Role: Pharmaceutical Sales SpecialistKey Responsibilities:Establish connections with healthcare professionals to promote pharmaceutical products and educate them on relevant topics.Develop targeted strategies to engage healthcare professionals in discussions about Red Flags for LSDs and Differential Diagnosis Pathways.Support interested healthcare...