Regulatory Affairs Specialist

2 days ago

Noida, Uttar Pradesh, India Devine Meditech Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Job Title:
Regulatory Affairs Specialist

Location:
Okhla Phase-1, Delhi-110020

Department:
Regulatory Affairs

Reports To:
Head of Quality & Regulatory

Employment Type:
Full-Time

Job Summary:

We are seeking a detail-oriented and knowledgeable
Regulatory Affairs Specialist
to ensure our medical devices comply with all regulatory requirements in domestic and international markets. The ideal candidate will have a strong understanding of medical device regulations (e.g., ISO 13485, MDR, US FDA 21 CFR Part 820) and a proven track record in managing regulatory submissions, documentation, and audits.

Key Responsibilities:

  • Prepare, compile, and submit regulatory documents for product approvals/registrations (e.g., CE Marking, US FDA 510(k), CDSCO India).
  • Review technical documentation for compliance with applicable standards and regulations.
  • Liaise with regulatory authorities and notified bodies for approvals, audits, and queries.
  • Maintain regulatory compliance of marketed products through timely renewals, amendments, and updates.
  • Monitor changes in regulatory requirements across key markets (e.g., EU, US, India, ASEAN) and communicate implications to internal stakeholders.
  • Support product development teams by providing regulatory strategy and guidance throughout the product lifecycle.
  • Participate in internal and external audits, inspections, and quality assurance initiatives.
  • Maintain regulatory databases, track submissions, and manage regulatory files and records.
  • Collaborate with cross-functional teams including Quality, R&D, Manufacturing, and Marketing.

Qualifications & Skills:

  • Bachelor's/Master's degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field.
  • 3–6 years of experience in regulatory affairs in the medical device industry.
  • Knowledge of medical device classification, risk assessment, and international standards (e.g., ISO 13485, ISO
  • Familiarity with country-specific regulatory bodies such as CDSCO (India), FDA (US), TGA (Australia), and EU MDR.
  • Strong documentation, communication, and project management skills.
  • Attention to detail and ability to interpret complex regulatory language.
  • Certification in Regulatory Affairs (e.g., RAPS) is a plus.

Preferred Experience:

  • Experience in preparing Design Dossiers or Technical Files.
  • Exposure to QMS implementation and validation protocols.
  • Hands-on with e-submissions, labeling review, and product recalls.

  • Cosmetics Regulatory Affairs Specialist

    2 days ago

    Noida, Uttar Pradesh, India Cbayexpress Technologies Full time US$ 90,000 - US$ 1,20,000 per year

    Job Position: Cosmetics Regulatory Affairs SpecialistWorking Days: Monday to FridayShift Time- 12 PM IST- 9 PM ISTOn-Site RoleWe are looking for a detail-oriented and knowledgeable Cosmetics Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory policies, documentation, and compliance requirements...

  • Cosmetics Regulatory Affairs Specialist

    2 weeks ago

    Greater Noida, Uttar Pradesh, India CbayExpress Full time ₹ 7,80,000 per year

    Job Position: Cosmetics Regulatory Affairs SpecialistWorking Days: Monday to FridayShift Time- 12 PM IST- 9 PM ISTLocation- Sector- 63, Noida We are looking for a detail-oriented and knowledgeable Cosmetics Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory policies, documentation, and...

  • Regulatory Affairs Executive

    6 days ago

    Noida, Uttar Pradesh, India SR Strategy Services Full time ₹ 3,00,000 - ₹ 6,00,000 per year

    Regulatory Executive (Medical Devices & IVDs)Experience:1–3 years inregulatory affairs for medical devices and/or IVDs under Indian MDR 2017Location:Noida (On-site)CTC :INR 3-6 LPAAbout SR Strategy Services LLP:SR Strategy Services LLP is a leading consulting firm specializing in strategic government affairs, regulatory advisory, market access solutions,...

  • Regulatory Affairs Associate

    1 day ago

    Greater Noida, Uttar Pradesh, India Steadfast Nutrition Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Roles and ResponsibilitiesPrepare dossiers, variations, renewals, and amendments for USFDA regulatory submissions.Coordinate with third-party agencies for audits and inspections (USFDA, WHO).Ensure compliance with GMP requirements through self-inspection and third-party audits.Maintain liaison with government authorities for licensing and approvals.Provide...

  • Manager, Regulatory Affairs

    20 hours ago

    Noida, Uttar Pradesh, India PharmaLex Full time ₹ 1,20,000 - ₹ 1,80,000 per year

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

  • Global Regulatory Affairs Expert

    2 weeks ago

    Noida, Uttar Pradesh, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000

    Regulatory SpecialistWe are seeking a highly skilled Regulatory Specialist to join our team. The ideal candidate will have extensive experience in managing regulatory systems and ensuring compliance with business goals and regulations.This role requires strong analytical skills, attention to detail, and the ability to communicate complex information...

  • Director of Regulatory Affairs

    4 weeks ago

    Noida, Uttar Pradesh, India Vahura Full time

    A leading Chartered Accountancy firm in Noida is seeking a dynamic leader to head its expanding Regulatory Division. This role offers the chance to shape strategy, drive growth, and deliver regulatory advisory and compliance solutions to prominent corporate clients across sectors. The right professional will bring at least 12 years of post-qualification...

  • Manager-Regulatory Affairs

    4 weeks ago

    Noida, Uttar Pradesh, India Jubilant Ingrevia Limited Full time

    Organization : - Jubilant Ingrevia Limited Designation & Level: - Deputy Manager (L3) Location : - Noida/Greater Noida/Gajraula/Mumbai/Bharuch/Vadodara/Savli/Nira/Ambernath/Hyderabad Direct Reports : - IC role Qualification: Master's degree in Toxicology, Pharmacology, Biochemistry, Chemistry or other life science. Experience Range: 7-12 years Job Context: ...

  • Manager-Regulatory Affairs

    3 weeks ago

    Noida, Uttar Pradesh, India Jubilant Ingrevia Limited Full time

    Organization : - Jubilant Ingrevia LimitedDesignation & Level: - Deputy Manager (L3)Location : - Noida/Greater Noida/Gajraula/Mumbai/Bharuch/Vadodara/Savli/Nira/Ambernath/HyderabadDirect Reports : - IC roleQualification:Master's degree in Toxicology, Pharmacology, Biochemistry, Chemistry or other life science.Experience Range:7-12 yearsJob Context: To...

  • Regulatory Executive Medical Devices

    6 days ago

    Noida, Uttar Pradesh, India SR Strategy Services Llp Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Role & responsibilitiesPrepare, compile, and assist in submission of regulatory applications/dossiers for medical devices and IVDs under MDR 2017.Support licensing/registration processes (Forms MD-5, MD-14, MD-15, MD-16, MD-24 etc.) for multiple products and clients.Liaise with CDSCO, State Licensing Authorities, and notified bodies during submission and...