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Regulatory Affairs Manager

7 years

0 Lacs

Ahmedabad Gujarat India

Posted:1 day ago| Platform: Linkedin logo

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Skills Required

strategy planning marketing inspection compliance mdr

Work Mode

On-site

Job Type

Full Time

Job Description

Location:

Experience:

Global Markets: Asia, Africa, ANZ, Europe, Middle East, LATAM



🔧 Key Responsibilities:

  • Lead global regulatory strategy, planning, and execution for product approvals
  • Manage medical device registrations across multiple international markets
  • Coordinate with cross-functional teams (Sales, Marketing, RA coordinators)
  • Oversee post-approval changes, document control, and inspection readiness
  • Ensure compliance with global standards:

    ISO 13485, MDSAP, EU MDR, 510(k), Indian MDR

  • Maintain and update RA policies, labels, IFUs, translations, and marketing claims
  • Train and lead a team of international RA professionals
  • Act as point of contact for global regulatory matters and external partners




📩 Apply Now:



📞 Contact Person:

Ansuya Satish / Anjali Batheja

9824350317 / 9723300064

Ansuya@uhr.co.in / Unitedind@uhr.co.in

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