Regulatory Affair Manager

2 weeks ago

Bengaluru, Karnataka, India Futura Surgicare Full time ₹ 20,00,000 - ₹ 25,00,000 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:

.

  • Regulatory Affairs Manager

    2 weeks ago

    Bengaluru, Karnataka, India Kumar Organic Products Full time

    Job Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...

  • Program Manager, Regulatory Affairs

    2 weeks ago

    Bengaluru, Karnataka, India GE Healthcare Private Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Program Manager, Regulatory Affairs, Maternal Infant Care Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of...

  • Regulatory Affairs

    7 days ago

    Bengaluru, Karnataka, India Surgeway Biosciences Private Limited Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    JOB TITLE :Regulatory Affairs - Senior Executive - ROW markets (Philippines, Kenya, Ethiopia, Nigeria)WHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES?As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training...

  • Regulatory Affairs

    1 week ago

    Bengaluru, Karnataka, India Sea6 Energy Pvt Ltd. Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Company Profile:At Sea6 Energy we envision a future where we can harness the potential of the oceans – to provide sustainable solutions in energy, agriculture and food. To accomplish this, a multidisciplinary team with professionals from diverse fields of science including Industrial automation, Biotechnology, Agriculture, Ocean Engineering, Bioprocess...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Bengaluru, Karnataka, India AliveCor Full time US$ 1,00,000 - US$ 1,50,000 per year

    DescriptionAt AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered...

  • Regulatory Affairs Manager- SME

    3 weeks ago

    Bengaluru, Karnataka, India, Karnataka Mount Talent Consulting Pvt Ltd. Full time

    Domain lead - SME - Safety and Regulatory - BA offshoreExpert in Pharma domain’s multiple functions especially Regulatory and SafetyWell versed with business functions and tools used by industryAble to create integrated solutions and able to address customer pain pointsAble to draw process flowsAct as Technical Product Owner for global regulatory systems...

  • Senior Manager, Global Regulatory Affairs

    7 days ago

    Bengaluru, Karnataka, India 50skills Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    We are looking for a Senior Manager to join our Global Regulatory Affairs team, specializing in Lifecycle Management (LCM) for Chemistry, Manufacturing, and Controls (CMC). CMC ensures that pharmaceutical products are consistently produced and meet quality standards during development and throughout their lifecycle.In this role, you will develop global...

  • Regulatory & Liaisoning Affairs Officer

    3 days ago

    Bengaluru, Karnataka, India Enerparc Energy Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job DescriptionAbout Company:Enerparc AG is a global expert in developing, engineering, building, and operating ground mount as well as roof mount photovoltaic (PV) systems. As an EPC contractor, our company has connected over 3400 MW of solar systems to electricity grids. With local presence in all active solar markets like Europe, Middle East & Asia, we...

  • Manager-Liaison & Regulatory Affairs (Renewable Energy)

    7 days ago

    Bengaluru, Karnataka, India Rays Power Infra Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Regulatory AffairsMonitor and analyze regulatory changes, tariff orders, grid codes, and policies issued by central (MoP, MNRE, CERC, CEA) and state authorities (KERC, KPTCL, CEIG, DISCOMs, SPCB).Assess the impact of regulatory updates on ongoing and upcoming projects and prepare briefs for management.Manage DPR/RFP documentation and compliance...

  • Regulatory Affairs Lead Specialist

    1 week ago

    Bengaluru, Karnataka, India GE Healthcare Private Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Lead Specialist, Regulatory Affairs - WHXR Job Description SummaryJoin GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging. This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to...