Regulatory Affair Manager

2 weeks ago

Bengaluru, Karnataka, India Futura Surgicare Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Position Title: Regulatory Affairs & QA Manager

Department: Quality & Regulatory Affairs

Location: Bangalore

Role Overview

The Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485, MDR, US FDA, and other relevant standards. This role is critical in bridging product development, regulatory submissions, audits, and market access, ensuring patient safety and product quality at all times.

Key Responsibilities

Regulatory Affairs:

  • Develop and implement regulatory strategies for product registration, approvals, and certifications (CE marking, US FDA, CDSCO, etc.).
  • Prepare, compile, and submit regulatory dossiers for global markets.
  • Act as liaison with regulatory authorities, notified bodies, and certification agencies.
  • Monitor changes in global regulatory requirements and assess impact on company products.
  • Support product labeling, claims, and advertising compliance with regulations.
  • Maintain regulatory databases, technical files, and Design Dossiers.

Quality Assurance:

  • Lead and maintain the companys Quality Management System (QMS) in line with ISO 13485, ISO Risk Management), MDR, and FDA QSR (21 CFR Part 820).
  • Plan, conduct, and manage internal and external audits (regulatory, customer, notified body).
  • Ensure effective CAPA (Corrective and Preventive Action) and complaint handling processes.
  • Oversee supplier qualification, incoming inspection, and vendor audits.
  • Ensure proper document control, change control, and training compliance.
  • Drive continuous improvement in quality systems, manufacturing processes, and compliance culture.

Cross-functional Support:

  • Work closely with R&D and Manufacturing for design control, risk assessment, and regulatory compliance during product development.
  • Support clinical evaluation, PMS (Post-Market Surveillance), and vigilance reporting.
  • Provide training and regulatory/quality guidance to internal teams.

Key Requirements

  • Education: Bachelors / Masters degree
  • Experience: Minimum 610 years in Regulatory Affairs and Quality Assurance in the medical device industry.
  • Strong knowledge of ISO 13485, MDR 2017/745, IVDR, US FDA 21 CFR Part 820, ISO 14971, IEC 60601, and other relevant standards.
  • Proven experience in regulatory submissions, audits, and product registrations.
  • Excellent understanding of QMS implementation and maintenance.
  • Strong analytical, documentation, and project management skills.
  • Effective communication and leadership skills to work with cross-functional teams and external regulators.

Kindly fill the below mentioned details

  • Notice Period:
  • Current Salary:
  • Expected Salary:
  • Current Address:
  • Experience in USFDA:
  • Experience in EU MdR:
  • Experience in CDSO:
  • Experience in Product Registration:
  • Availability for a Google Meet interview
  • Preferred Date:
  • Preferred Time:

Kindly share your update resume to .limited or WhatsApp:

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