Medical Device Regulatory Specialist

4 weeks ago

Odhav, India Frisch Medical Devices PVT LTD Full time

Job Title: Regulatory Affairs Junior Manager


Location: At Ahmedabad Office, Near Thaltej Crossroads

Department: RA

Reports To: RA Head and Regulatory Department at HO /Director

Employment Type: Full Time

Office hours : 9,30 AM to 6 PM

Week of: Sunday and Saturday Half Day

Preferred Gender : M/F

Experience: Minimum 2 years



Job Summary:

We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices. The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.



Key Responsibilities:

  • Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.G., US FDA, EU MDR, India CDSCO, etc.).
  • Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
  • Support product development teams with regulatory input during the design and development phases.
  • Conduct regulatory impact assessments for design or process changes.
  • Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
  • Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
  • Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
  • Assist in internal audits and inspections, including document preparation and response coordination.
  • Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
  • Participate in risk management, clinical evaluation, and post-market surveillance activities.



Qualifications:

  • Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
  • Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices.
  • Knowledge of medical device regulations such as EU MDR, US FDA 21 CFR Part 820, ISO 13485, and CDSCO requirements.
  • Experience in dossier preparation (e.G., 510(k), PMA, CE technical files).
  • Strong analytical, organizational, and communication skills.
  • Attention to detail and ability to work independently as well as in a team environment.



Preferred Qualifications:

  • Certification in Regulatory Affairs (e.G., RAC) is a plus.
  • Experience interacting with regulatory bodies or notified bodies.
  • Familiarity with eCTD or electronic submission platforms.


  • Medical Device Regulatory Specialist

    3 weeks ago

    Odhav, India Frisch Medical Devices PVT LTD Full time

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

  • Medical Device Production Manager

    2 weeks ago

    Odhav, India MEDIPLUS® | Shree Umiya Surgical Pvt. Ltd. Full time

    Job Summary:The Plant Head will be responsible for overall management, planning, and control of plant operations — ensuring optimum utilization of manpower, materials, and machinery while maintaining the highest standards of productivity, quality, safety, and regulatory compliance (ISO 13485, CE, MDR, GMP).This role requires a strong leader who can align...

  • Regulatory Affairs Officer

    1 week ago

    Odhav, Ahmedabad, Gujarat, India Nest Healthcare Pvt Ltd Full time

    **Position**: Regulatory Affairs Specialist **Location**: Odhav. Ahmedabad **Department**: Regulatory Affairs **Reports to**: Regulatory Affairs Manager / Director Job Summary: Key Responsibilities: - **Compliance Monitoring**: Monitor changes in regulations and guidelines to ensure ongoing compliance with local and international regulations. -...

  • Export Marketing Coordinator

    2 weeks ago

    Odhav, India MEDIPLUS® | Shree Umiya Surgical Pvt. Ltd. Full time

    Job Summary:The International Marketing Executive will be responsible for driving global marketing initiatives, maintaining and expanding the international lead database, supporting sales teams with qualified leads, and ensuring consistent brand visibility across all target countries. This role involves analytical, creative, and strategic marketing skills to...

  • International Sales Executive

    2 weeks ago

    Odhav, India MEDIPLUS® | Shree Umiya Surgical Pvt. Ltd. Full time

    Job Summary:The International Sales Executive will be responsible for driving overseas sales, managing distributor relationships, achieving sales targets, and expanding the company’s global footprint across assigned countries. The role involves handling end-to-end sales activities — from lead follow-up and quotation to order closing, documentation...

  • AI Innovation

    2 weeks ago

    Odhav, India ACL Digital Full time

    Job Function, Roles & Responsibilities: - Lead strategic initiatives and own the practice for Edge AI/ML, data pipelines, and intelligent embedded systems - Define and build the competency roadmap for machine learning, deep learning, model deployment, and real-time inferencing on edge platforms - Oversee data creation — including data collection, dataset...

  • M&A Transaction Advisor

    2 weeks ago

    Odhav, India Adani Group Full time

    Role Purpose: The M&A and Structuring Specialist supports Adani Corporate Services in executing strategic initiatives through mergers, acquisitions, joint ventures, and corporate restructuring. The role focuses on enhancing operational efficiency, ensuring regulatory compliance, and aligning transactions with the Adani Group’s vision of sustainable growth...

  • Semiconductor R&D Specialist

    4 weeks ago

    Odhav, India Tata Electronics Full time

    Tata Electronics Private Limited (TEPL) is a greenfield venture of the Tata Group with expertise in manufacturing precision components.Tata Electronics (a wholly owned subsidiary of Tata Sons Pvt. Ltd.) is building India’s first AI-enabled state-of-the-art Semiconductor Foundry. This facility will produce chips for applications such as power management IC,...

  • Education Enrollment Specialist

    2 weeks ago

    Odhav, India upGrad Full time

    Academic Counsellor – Offline Learning Centre (Jaipur/Ahmedabad)Location: Jaipur/AhmedabadWorking Days: Monday – SaturdayPackage: Upto 5 LPAAbout upGrad:Founded in 2015, upGrad is Asia’s largest integrated Learning, Skilling, and Workforce Development company, empowering 10M+ learners across 100+ countries through programs in Management, Data Science,...

  • Rail Network Deployment Specialist

    2 weeks ago

    Odhav, India Digital Reach Pvt.Ltd Full time

    Job Posting: Electrical Site Manager ( Railway )Location: Pan-India (Railway sites) Company: Digital Reach Pvt.Ltd Project: IR-NIYANTRAC – Indian RailwaysAbout the RoleWe are hiring an IFD Panel Installation Site Manager to lead the installation, testing, and commissioning of Intelligent Field Device (IFD) panels for Indian Railways’ IR-NIYANTRAC...