Regulatory Affairs Associate

1 day ago

Surat, Gujarat, India Concept Medical Full time
About Us:

Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the Netherlands to further our mission of saving lives and improving patient care.

Job Summary:

We are seeking a dedicated and knowledgeable Regulatory Specialist to ensure our medical devices meet local and international regulatory standards. The ideal candidate will have extensive knowledge of CDSCO, ISO, FDA, and other regulatory requirements, ensuring the highest standards of safety and efficacy for our products.

Key Responsibilities:

- Develop regulatory strategies for new/existing products.

- Ensure compliance with local/international regulations (CDSCO, ISO, FDA).

- Prepare and submit regulatory submissions.

- Monitor regulatory developments and adjust strategies.

- Liaise with regulatory bodies and internal teams for compliance.

- Conduct audits and maintain up-to-date knowledge of regulatory requirements.

Required Qualifications:

- Bachelor's degree in a scientific discipline.

- 2 to 3 years' experience in regulatory affairs within the medical device industry.

- In-depth knowledge of CDSCO, ISO, FDA standards.

- Experience with regulatory submissions and medical device development.

- Excellent communication, organizational, and project management skills.

Preferred Qualifications:

- Advanced degree (Master's/Ph.D.).

- Professional certification in regulatory affairs (RAC).

  • Regulatory Affairs

    18 hours ago

    Surat, Gujarat, India Concept Medical Full time

    Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...

  • Regulatory Affairs Manager

    2 days ago

    Surat, Gujarat, India Seven Consultancy Full time

    JOB DETAILS Studying scientific and legal documentsGathering, evaluating, organising, managing and collating information in a variety of formatsEnsuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)Maintaining familiarity with company product rangesPlanning, undertaking and overseeing product trials and...

  • Regulatory Affairs Specialist

    16 hours ago

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

    Regulatory SpecialistWe are seeking a dedicated and knowledgeable Regulatory Specialist to join our team. This role is responsible for ensuring our medical devices meet local and international regulatory standards.The ideal candidate will have extensive knowledge of CDSCO, ISO, FDA, and other regulatory requirements, ensuring the highest standards of safety...

  • Regulatory Affairs Manager

    1 day ago

    Surat, Gujarat, India Red Envelope Consultants Full time

    Job Title: Senior Regulatory Manager – RoW MarketDepartment: Regulatory AffairsJob Summary:The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended for Rest of the World (RoW) markets, ensuring compliance with country-specific...

  • Regulatory Affairs Manager Position

    24 hours ago

    Surat, Gujarat, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 12,00,000

    Regulatory Compliance Specialist RoleThe ideal candidate will be responsible for ensuring our medical devices meet local and international regulatory standards.Develop strategic approaches to regulatory compliance for new/existing products.Verify adherence to local/international regulations (CDSCO, ISO, FDA).Prepare and submit comprehensive regulatory...

  • Senior Leadership Position for Food Regulatory Affairs

    8 hours ago

    Surat, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 21,99,999

    Lead Food Regulatory Affairs ExpertWe are seeking a highly skilled and motivated individual to drive policy initiatives, engage with industry stakeholders, generate revenue, and organize impactful initiatives in the Food Regulatory Affairs domain.Job Overview:As a Lead Food Regulatory Affairs Expert, you will be responsible for analyzing food regulations,...

  • Regulatory Affairs Lead for Generic Product Compliance

    2 weeks ago

    Surat, Gujarat, India beBeeCompliance Full time ₹ 40,00,000 - ₹ 50,00,000

    **Job Title:** Senior Regulatory Affairs Specialist About the Role:We are seeking a seasoned professional to lead and manage CMC regulatory activities for USFDA submissions. As our ideal candidate, you will be responsible for overseeing the compilation and submission of Annual Reports, amendments, and deficiency responses. Main Responsibilities:Lead and...

  • Senior Regulatory Affairs Specialist

    2 days ago

    Surat, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Summary:We are seeking a skilled Regulatory Affairs specialist to support our end-to-end submissions for global markets.This role requires the ability to manage lifecycle management, Veeva Vault RIM, and complex initial and variation submissions.Main Responsibilities:Prepare Variation documents and evaluate post-approval CMC changes in compliance with...

  • Director of Public Affairs

    3 days ago

    Surat, Gujarat, India beBeePublic Full time ₹ 1,03,09,000 - ₹ 2,06,18,000

    Policy StrategistDeputy Manager with focus on public policy development.Location: Gurugram (On-Site)Key ResponsibilitiesForge relationships with policymakers, regulators, and government stakeholders to advance business objectives.Lead advocacy efforts across industry associations, think tanks, and other collective forums to strengthen position in sectoral...

  • Regulatory Compliance Expert

    1 day ago

    Surat, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000

    About us, we are at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare drives us to provide best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team to further our mission of saving lives and...