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Head- Regulatory Affairs

Bangalore Urban Permanent View Job Description
The Regulatory Affairs Head will lead and oversee import-related regulatory strategies, ensuring timely approvals and full compliance with local regulations and industry standards in the life sciences sector.
  • Drive regulatory strategy with global impact at a leading healthtech innovator
  • Leadership role with strong visibility and growth potential

About Our Client

This opportunity is with a global MNC recognized for its contributions to the life sciences industry.

Job Description

  1. Regulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals.
  2. Leadership and Team Management- Build and lead a high-performing regulatory team, fostering a culture of excellence, innovation, and accountability.
  3. Regulatory Submissions and Approvals- Oversee the preparation, submission, and maintenance of regulatory dossiers.
  4. Compliance Oversight- Ensure that the equipments meet the required regulatory standards as set by CDSCO.
  5. Cross-functional Collaboration- Partner with Govt affairs, Quality, Business Areas, Marketing and Legal team to integrate regulatory requirements.

The Successful Applicant

Education:

  • Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related fields. Advanced degrees (e.g., MBA, Ph.D.) are an advantage. *



Experience:

  • Minimum 10-15 years of regulatory experience (preferably in IVD), with at least 5 years in a leadership role.
  • In-depth understanding of India's Medical Devices Rules, 2017, CDSCO guidelines, and applicable standards (e.g., ISO 13485, ISO 14971).
  • Familiarity with global regulations like FDA (21 CFR), EU MDR/IVDR, and other regional requirements for international market access.
  • Proven track record of managing regulatory strategies for medical device company.
  • Exceptional leadership, communication, and negotiation skills.
  • Strategic thinker with a proactive approach to problem-solving.
  • Ability to navigate complex regulatory landscapes while maintaining agility

What's on Offer



  • Leadership opportunity to head regulatory affairs for imports, driving compliance and approvals for advanced life sciences technologies.


  • Strategic exposure to regulatory authorities and global stakeholders, influencing market entry and product availability.


  • Platform to shape and strengthen the organization's regulatory framework while working with cutting-edge healthcare innovations.
Quote job ref
JN-032025-6688109

Job summary

Function
Healthcare & Life Sciences
Sub Sector
Regulatory Affairs
What is your area of specialisation?
Life Sciences / Diagnostics
Location
Bangalore Urban
Job Type
Permanent
Job Reference
JN-032025-6688109

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.