Head Quality and Regulatory

Bangalore Permanent View Job Description
This role leads the setup and management of quality and regulatory functions for a new medical implant manufacturing company, ensuring compliance with ISO 13485 and Indian regulatory requirements. It involves building systems and a team from scratch while collaborating closely with global teams to support certification, clinical affairs, and operational scale-up.
  • Lead India QA RA setup
  • Build quality and regulatory roadmap

About Our Client

A fast-growing global medical technology company specializing in high-quality orthopedic implants and surgical solutions. The organization has a strong international presence and is expanding its manufacturing footprint in India, combining global expertise with local innovation.

Job Description

  • Lead quality & regulatory setup for a new medical implant manufacturing facility in India
  • Establish and manage QMS aligned with ISO 13485 and global standards
  • Drive regulatory approvals and compliance with Indian authorities (CDSCO)
  • Oversee process validation, equipment qualification, and clinical activities
  • Build and scale the quality & regulatory team while collaborating with global stakeholders

The Successful Applicant

  • 8+ years in medical device quality/regulatory roles (preferably Class II/III implants)
  • Strong expertise in ISO 13485 and CDSCO regulatory frameworks
  • Experience in setting up or scaling QA systems in new/greenfield environments
  • Proven leadership in building and managing high-performing teams
  • Excellent cross-functional and global stakeholder communication skil

What's on Offer

  • Opportunity to build and lead the quality & regulatory function from the ground up
  • Work in a high-impact role with strong visibility to leadership and global teams
  • Exposure to international standards and collaboration with experienced global experts
  • Fast-paced growth environment with opportunities to scale a team and function
  • Competitive compensation with long-term career development potential



If you are passionate about quality and compliance in the healthcare sector, apply now to join a growing organization in Ebene.

Quote job ref
JN-052026-7029110

Job summary

Function
Healthcare & Life Sciences
Sub Sector
Manufacturing / Quality
What is your area of specialisation?
Medical Device / Medical Equipment
Location
Bangalore
Job Type
Permanent
Job Reference
JN-052026-7029110

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.