Regulatory Affairs Specialist

5 years

0 Lacs

Posted:1 day ago| Platform: Linkedin logo

Apply

Work Mode

On-site

Job Type

Full Time

Job Description

Job Title:

Location:

Department:

Reports To:

Employment Type:

Job Summary:

Regulatory Affairs Specialist

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.
  • 3–5 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 14971).
  • 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 (Optional):

  • 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.

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

RecommendedJobs for You