Current jobs related to Medical Device Regulatory Affairs Manager - Vadodara, Gujarat - beBeeRegulatoryAffairs

  • Medical Affairs Specialist

    2 weeks ago

    Vadodara, Gujarat, India beBeeMedicalAffairs Full time ₹ 35,00,000 - ₹ 40,00,000

    **Job Title:** Medical Affairs StrategistAbout the Role:The General Manager of Medical Affairs will lead medical affairs strategies, providing robust medico-marketing support and facilitating collaboration between medical and marketing teams. This role encompasses the development of medical materials, training programs, and evaluation of new products to...

  • Regulatory Affairs Project Manager

    1 week ago

    Vadodara, Gujarat, India beBeeRegulatoryAffairspartner Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Job Overview:As a key member of our Regulatory Affairs team, you will be responsible for the compilation and submission of regulatory documents to various markets, including the US, EU, AU, Canada, IL, and Palestine. You will work closely with stakeholders to review and manage all aspects of dossier compilation, query response, and lifecycle management.About...

  • Global Regulatory Affairs Strategist

    2 weeks ago

    Vadodara, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 1,80,00,000 - ₹ 2,10,00,000

    Global Regulatory Affairs StrategistKey Responsibilities:Develop and direct global regulatory strategies covering clinical, non-clinical, and CMC aspects.Lead the preparation, review, and approval of submission dossiers for regulatory authorities including US FDA, EMA, Health Canada, Australia's TGA, and ANVISA (Brazil).Provide strategic guidance on...

  • Executive Regulatory Affairs

    2 days ago

    Vadodara, Gujarat, India Exemed Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna.Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement.To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement.Responsible for prepare and review...

  • Medical Device Quality Assurance Professional

    2 weeks ago

    Vadodara, Gujarat, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000

    **Job Summary:**A highly skilled Quality Assurance Specialist is sought to implement and maintain a quality management system (QMS) ensuring our products meet quality, safety, and regulatory standards.Key Responsibilities:* Implementing and maintaining a QMS (like ISO 13485)* Identifying, interpreting, and ensuring adherence to relevant medical device...

  • Medical Devices Technical Lead

    2 weeks ago

    Vadodara, Gujarat, India beBeeDeviceDeveloper Full time ₹ 25,00,000 - ₹ 30,00,000

    Job OverviewThe role involves leading device development for Meter Dose Inhaler dosage form, requiring coordination with device manufacturers, selection of the right device, and ensuring design verification complies with defined user requirements.Test method/fixtures development, relevant testing, validation, in-silico clinical simulations are also key...

  • Regulatory Affairs Expert

    2 weeks ago

    Vadodara, Gujarat, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 15,00,000

    Regulatory Affairs SpecialistThis is a key role in ensuring regulatory compliance across various product categories. The successful candidate will be responsible for preparing, reviewing and maintaining regulatory documents to meet international guidelines and country-specific requirements.The role involves close coordination with internal teams and external...

  • Cardiac Medical Device Security Specialist

    2 weeks ago

    Vadodara, Gujarat, India beBeeSecurity Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Product Security Leadership OpportunityRole Overview:We are seeking a strategic Product Security leader to drive the development, implementation, and monitoring of security solutions for cardiac medical devices and infrastructure.Key Responsibilities:Manage a team of engineers and cybersecurity professionals dedicated to product security for cardiac medical...

  • Senior Medical Device Specialist

    2 weeks ago

    Vadodara, Gujarat, India beBeeBiomedical Full time ₹ 10,00,000 - ₹ 20,00,000

    Job DescriptionInochi Care focuses on developing medical technologies for the accelerated healing of chronic wounds, such as diabetic foot ulcers, pressure sores, and post-trauma wounds. The company's innovative products are designed to heal non-healing wounds through technology-led solutions. The technology has been developed under the School of...

  • Medical Segment Innovator

    2 weeks ago

    Vadodara, Gujarat, India beBeeInnovation Full time ₹ 1,20,00,000 - ₹ 3,00,00,000

    We are seeking a visionary leader to spearhead our medical segment in India. As a Medical Segment Lead, you will leverage your expertise in medical devices, regulatory frameworks, and cross-functional team management to drive business growth.Key ResponsibilitiesYou will develop and execute a strategic vision for the medical segment, aligning with global...

Medical Device Regulatory Affairs Manager

3 weeks ago

Vadodara, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 25,00,000

We are seeking a highly qualified professional to assume the role of Regulatory Affairs Manager in the Medical Device Industry.

Job Summary:

The ideal candidate will be responsible for ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.

Key Responsibilities:
  • Coordinate with regulatory authorities such as FDA and CDSCO for obtaining required 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 and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
  • Support audits, inspections, and ensure readiness for regulatory authority reviews.
Required Skills and Qualifications:
  • 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.