Medical Device Regulatory Affairs Specialist

2 days ago

Bhopal, Madhya Pradesh, India Imdsl Laser Full time US$ 90,000 - US$ 1,20,000 per year

Job Title:

Medical Device Regulatory Affairs Specialist

Bhopal Location

Company:

Intense Medical & Dental System Pvt Ltd, Bhopal.

Job Brief:

We are looking for a skilled Regulatory Affairs Specialist
to manage and coordinate regulatory compliance for our medical devices. This role requires strong communication with channel partners, collaboration with documentation teams, and ensuring all products meet regulatory standards for both domestic and international markets.

Key Responsibilities:


• Ensure medical devices comply with all applicable national and international regulatory requirements and standards


• Prepare and submit regulatory submissions, including 510(k), PMA, and other global market registrations


• Communicate with regulatory authorities (such as the FDA, CDSCO) to handle queries and support approval processes


• Monitor and interpret changes in medical device regulations and assess their impact on the company


• Provide regulatory guidance and training to cross-functional teams including R&D, QA/RA, and Product Development


• Develop and implement regulatory strategies to support new product development and market expansion


• Maintain organized, up-to-date documentation to demonstrate compliance and support audits


• Collaborate with channel partners and internal documentation specialists to ensure consistent regulatory alignment

Requirements:


• Bachelor's degree in Biomedical Engineering, or B.E electronic commination. or a related discipline


• 3–4 years of experience in medical device regulatory affairs


• Strong knowledge of domestic and international medical device regulations (FDA, EU MDR, ISO 13485, CDSCO, etc.)


• Excellent verbal and written communication skills


• High attention to detail, analytical thinking, and problem-solving ability


• Experience working collaboratively across multiple teams

Preferred Qualifications:


• Regulatory Affairs Certification (RAC)


• Experience with Class II or III medical devices


• Familiarity with quality systems (e.g., ISO 13485, FDA QSR)

  • Contact No

  • Regulatory Affairs Specialist

    2 days ago

    Bhopal, Madhya Pradesh, India Intense Medical & Dental System Pvt. Ltd. Full time ₹ 419 per year

    OverviewDevelop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.Conduct internal audits, CAPA (Corrective & Preventive Action), and risk assessments to ensure ongoing compliance.Monitor production processes and verify adherence to SOPs, specifications, and quality...

  • QA QC Engineer

    2 days ago

    Bhopal, Madhya Pradesh, India Intense Medical Dental System Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Responsible for ensuring medical devices meet quality standards and regulatory compliance through Quality Management Systems (ISO 13485, FDA 21 CFR Part 820), audits, inspections, and process improvements. Quality Control: Perform in-process & final

  • QA/QC Engineer

    2 days ago

    Bhopal, Madhya Pradesh, India Intense Medical & Dental System Pvt. Ltd. Full time ₹ 4,23,831 per year

    Job Description – QA & QC Engineer (Medical Devices)Position SummaryThe QA & QC Engineer is responsible for ensuring that all medical devices meet quality standards, regulatory requirements, and organizational policies. The role involves implementing quality systems, performing inspections, conducting audits, and supporting regulatory submissions to ensure...

  • Sales and service executive

    2 days ago

    Bhopal, Madhya Pradesh, India Three Points Medical Systems Full time US$ 60,000 - US$ 1,20,000 per year

    Company DescriptionThree Points Medical Systems is a medical device supplier dedicated to transforming the healthcare landscape through a holistic fusion of cutting-edge technology and domain knowledge. Our innovative solutions aim to enhance medical device efficiency and patient care. Located in Bhopal, we are committed to revolutionizing the industry with...

  • Territory Manager

    24 hours ago

    Bhopal, Madhya Pradesh, India Lyvex Medical Devices Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionLyvex Medical Devices Private Limited, promoted by NEON Group, is a leader in Anaesthesia and Critical Care. We specialize in manufacturing, marketing, and exporting high-quality medical devices. Our commitment to international standards ensures essential and reliable medical devices for various healthcare needs.Role DescriptionThis is a...

  • Distinguished Medical Imaging Specialist

    5 days ago

    Bhopal, Madhya Pradesh, India beBeeRadiologist Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title:Distinguished Medical Imaging SpecialistAbout the Position:We are seeking a skilled Radiologist to join our multidisciplinary team at a reputable hospital. The ideal candidate will have expertise in diagnostic imaging and a strong commitment to delivering high-quality patient care.Key Responsibilities:Perform and interpret various diagnostic...

  • Medical Imaging Specialist

    6 days ago

    Bhopal, Madhya Pradesh, India beBeeRadiology Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job Title: Medical Imaging SpecialistAbout Our Hospital:We are a leading healthcare provider dedicated to delivering quality medical care with compassion and advanced technology.Key ResponsibilitiesPerform and interpret diagnostic imaging procedures, including X-ray, Ultrasound, CT, MRI, Mammography, etc.Provide accurate and timely radiology reports to...

  • Healthcare Leadership Role

    4 days ago

    Bhopal, Madhya Pradesh, India beBeeExecutive Full time ₹ 20,00,000 - ₹ 30,00,000

    Job Summary:Pursue a leadership role as a strategic healthcare executive, focusing on the Central Nervous System (CNS) therapeutic area. Drive sales outcomes for Nurtec by engaging with healthcare professionals and promoting its scientific value and patient benefits.This position serves as the primary interface between Pfizer and the medical community,...

  • General Surgeon

    2 days ago

    Bhopal, Madhya Pradesh, India Career Institute of Medical Sciences Full time ₹ 1,04,000 - ₹ 13,08,780 per year

    To conduct initial consultations, evaluations, and follow-ups to diagnose and manage various medical conditions.To Perform a wide range of surgical operations, such as appendectomies, hernia repairs, and tumor resections.To Manage patient care before, during, and after surgery, including anesthesia, pain management, and wound care.To Diagnose and treat...

  • It Infrastructure Manager

    4 weeks ago

    Bhopal, Madhya Pradesh, India Gvk Emergency Management And Research Institute Gvk Emri Full time

    Job DescriptionIT Infrastructure ManagerGVK Emergency Management and Research Institute (GVK EMRI) is seeking a skilled IT Infrastructure Manager to oversee the entire IT operations within our hospital environment in Hyderabad, Telangana. This pivotal role encompasses managing the Hospital Management System (HMS), integrating medical devices, ensuring robust...