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Senior Regulatory Affairs Specialist

Location

India

Posted

87 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

Senior Regulatory Affairs Specialist

Danaher Corporation

• Manage India regulatory activities for medical devices, including registrations, renewals, variations, labelling compliance and lifecycle management • Compile and submit registration documents, liaise with regulatory authorities and consultants to ensure timely approvals • Assess regulatory impact of post-approval changes including design changes, labeling changes, warehouse changes, supplier or manufacturing site changes • Support post‑market regulatory activities, including Adverse Event reporting, Field Safety Corrective Action (FSCA)/Recall • Monitor and communicate regulatory intelligence and assess impact; maintain regulatory documentation and databases, utilize Regulatory Information Management Systems (Veeva RIM) • Support assigned regulatory activities across ASEAN markets to enable compliance and business objectives

Job Requirements

  • Bachelor’s Degree/ Diploma in Life Sciences, Engineering or other related discipline
  • Minimum 3 years of RA experience within medical device industry
  • Experience with India CDSCO submissions for medical devices
  • Good knowledge of India MDR & ASEAN regulatory frameworks
  • Working knowledge of ISO 13485 requirements
  • Strong written and communication skills
  • Ability for minimal travel required at 10% or less within India and abroad

Benefits

  • Health care program
  • Paid time off
  • Flexible working arrangements
  • Professional development opportunities

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