Regulatory Affairs Manager

12 hours ago

Delhi, Delhi, India Ace Cathtech Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 9,00,000 per year

Company Description

Ace Cathtech Pvt Ltd, established in April 2024, is a cutting-edge manufacturer of premium medical devices, specializing in Nephrology Products, Cardiac Surgery Equipment, Critical Care, and Anesthesia Products. Located in Faridabad, Haryana, our state-of-the-art facility adheres to the highest manufacturing standards, including a Class 7 cleanroom environment as per CDSCO guidelines. Our team follows strict Standard Operating Procedures (SOPs) to ensure quality control and patient safety. We are committed to delivering innovative solutions that enhance patient care and well-being.

Job Title:
Regulatory Affairs Manager

Department
: Regulatory Affairs

Location:
IMT, Sector-68, Faridabad

Employment Type:
Full-Time

Salary :
50k-60k (Negotiable)

Position Summary:

The Regulatory Affairs Manager is responsible for managing and overseeing regulatory activities to ensure that the company's medical products (e.g., medical devices, diagnostics, healthcare equipment) comply with applicable global regulatory requirements. This role supports product development, registration and post-market activities by providing strategic regulatory guidance and managing submissions to regulatory authorities such as the FDA, EMA, MHRA and other global agencies.

Key Responsibilities:

  • Develop and execute regulatory strategies to support new product development, international registrations, and post-market compliance.
  • Prepare, review and submit regulatory filings such as 510(k), PMA, CE Mark technical files, Design Dossiers and other country-specific submissions (e.g., TGA, Health Canada).
  • Ensure compliance with applicable standards and regulations (e.g., FDA 21 CFR 820, ISO 13485, MDR 2017/745, IVDR).
  • Serve as the primary liaison with regulatory bodies, managing responses to inquiries, deficiency letters and audits.
  • Monitor and interpret changes in global regulations that may affect the company's products and proactively communicate implications to internal teams.
  • Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs and Manufacturing to ensure regulatory requirements are integrated into product development processes.
  • Support product labeling, advertising, and promotional review for regulatory compliance.
  • Lead or assist in regulatory inspections and internal audits.
  • Maintain regulatory documentation, submissions, and approvals in accordance with internal SOPs and external regulations.
  • Mentor or supervise junior regulatory staff as needed.

Qualifications:

Education: Bachelor's degree must.

Experience:

  • 5+ years of regulatory affairs experience in the medical device or diagnostics industry.
  • Hands-on experience with FDA submissions (510(k), PMA), CE Marking and international regulatory requirements.
  • Knowledge of quality management systems and regulatory frameworks (e.g., ISO 13485, MDSAP, EU MDR/IVDR).

Skills:

  • Strong understanding of global medical device regulations.
  • Exceptional organizational, analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple projects with shifting priorities.
  • Detail-oriented and proactive in resolving issues and ensuring compliance.

  • Senior Manager Regulatory Affairs

    4 days ago

    Delhi, Delhi, India Panacea Biotec Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Position:Sr. Manager / AGM – Regulatory AffairsQualification:M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)Experience:13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...

  • Regulatory Affairs Officer

    16 hours ago

    Delhi, Delhi, India Edusoft Healthcare Limited Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Company DescriptionEdusoft Healthcare Limited is at the forefront of healthcare innovation, delivering top-notch radiology equipment for better diagnostics and patient outcomes. We are dedicated to redefining radiology excellence through our cutting-edge technology and solutions. Our mission is to enhance patient care and improve diagnostic accuracy. Join us...

  • Regulatory Affairs Executive

    1 week ago

    Delhi, Delhi, India Oswal Crop Protection Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionOswal Crop Protection Pvt. Ltd. is an ISO 9001:2015 certified company, established by Mr. Ramesh Bansal, who has over 30 years of experience in the pesticides industry. As one of the leading agrochemical companies in India, Oswal Crop Protection is committed to strengthening agriculture with sustainable products and services. Our marketing...

  • Senior Manager Regulatory Affairs

    5 days ago

    New Delhi, Delhi, India, Delhi Panacea Biotec Full time

    Position: Sr. Manager / AGM – Regulatory AffairsQualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...

  • Regulatory Affairs Executive

    2 weeks ago

    Delhi, Delhi, India Savvi Sales & Services Full time ₹ 2,40,000 - ₹ 12,00,000 per year

    Job Title: Regulatory Affairs ExecutiveLocation: Rohini, DelhiIndustry: Pharmaceuticals / NutraceuticalsSalary Package: 25,000 50,000 per monthGender Preference: MaleExperience Required: 2–3 years in Pharma or Nutra Industry (Regulatory Affairs)Key Responsibilities:Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs, MAAs.Ensure proper...

  • Regulatory Affairs Executive

    2 weeks ago

    Delhi, Delhi, India SAVVI SALES AND SERVICE PVT. Full time ₹ 2,50,000 - ₹ 3,00,000 per year

    Job Title: Regulatory Affairs ExecutiveLocation: Rohini, DelhiIndustry: Pharmaceuticals / NutraceuticalsSalary Package: ₹25,000 – ₹50,000 per monthGender Preference: MaleExperience Required: 2–3 years in Pharma or Nutra Industry (Regulatory Affairs)Key Responsibilities:● Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs, MAAs.●...

  • Compliance and Regulatory Affairs Manager

    2 days ago

    Delhi, Delhi, India Wonder Products Group of Companies Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Seeking Compliance & Regulatory Affairs Manager (5+ yrs exp) at Wonder Products, NSP Delhi. Ensure global/domestic compliance, manage submissions, labeling & audits. Apply now

  • Senior Executive – Regulatory Affairs

    2 weeks ago

    Delhi, Delhi, India Food Industry Asia (FIA) Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    About The RoleThe Nutrition Policy Specialist will report to Regional Senior Manager (Nutrition). This role will be instrumental in driving FIA's mission to represent and support the food and beverage (F&B) industry across Asia. This role involves monitoring regulatory developments, providing expert guidance on health and nutrition policies, and supporting...

  • Regulatory Affairs Specialist

    17 hours ago

    Delhi, Delhi, India DSS Imagetech Pvt Ltd Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    This is a full-time, on-site position based in New Delhi for a Regulatory Affairs Specialist. The role involves effective communication and coordination withboth internal teams and external stakeholders to ensure regulatory compliance and smooth operational workflows.Key Responsibilities:Develop and implement procedures to ensure regulatory compliance across...

  • senior regulatory affairs Executive

    1 week ago

    Delhi, Delhi, India LegalRaasta Technologies Pvt Ltd Full time ₹ 4,20,000 - ₹ 5,40,000 per year

    We are seeking a Senior Regulatory Affairs Executive with strong expertise in medical devices. The role involves handling end-to-end regulatory compliance, preparing and submitting dossiers, coordinating with CDSCO, managing product approvals, and ensuring adherence to medical device regulations. Candidate should have good knowledge of MDR, BIS, ISO 13485,...