Head Quality and Regulatory

Michael Page; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Competitive compensation

Long-term career development

Exposure to international standards

Job summary

Michael Page seeks a leader for their quality and regulatory setup for a new medical implant manufacturing facility in India. The role involves establishing quality management systems compliant with ISO standards and ensuring regulatory approvals with Indian authorities.

Ideal candidates will have over 8 years in regulatory roles, experience in QA systems, and proven leadership skills. This is a high-impact position offering competitive compensation and opportunities for career development.

Qualifications

• 8+ years in medical device quality/regulatory roles, especially in Class II/III implants.
• Strong expertise in ISO 13485 and CDSCO regulatory frameworks.
• Experience setting up QA systems in new environments.

Responsibilities

• Lead quality & regulatory setup for new medical implant manufacturing facility.
• Establish and manage QMS aligned with global standards.
• Drive regulatory approvals and compliance with Indian authorities.

Skills

ISO 13485 compliance

Regulatory approvals with CDSCO

Building and managing teams

Process validation

Cross-functional communication

Job description

• 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 skill

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.