Regulatory Affairs Specialist

1 day ago

Noida, Uttar Pradesh, India Devine Meditech Full time US$ 80,000 - US$ 1,20,000 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.

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