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Regulatory Affairs Head

Bangalore Permanent View Job Description
The Head of Regulatory Affairs - India will lead regulatory strategy and compliance efforts to ensure successful registration, approval, and lifecycle management of medical devices in alignment with both national and international standards. This senior role requires an experienced leader to manage regulatory submissions, engage with authorities like CDSCO, and drive cross-functional collaboration to support innovation, quality, and business objectives.
  • Opportunity to work with a global medical equipment company
  • Opportunity to take on a leadership role and contribute to the company's vision

About Our Client

Our client is a leading global medical technology company that provides innovative solutions in diagnostic and therapeutic imaging, laboratory diagnostics, and digital health services.

Job Description

1.Regulatory Strategy Development

  • Define and drive the regulatory vision and strategy for CRM products, aligning with Healthineers business goals.
  • Establish a roadmap for regulatory submissions, approvals, and compliance for new and existing product lines.
  • Lead initiatives to address regulatory challenges in emerging areas, such as digital health, artificial intelligence, and interoperability.



2. Leadership and Team Management

  • Build and lead a high-performing regulatory team, fostering a culture of excellence, innovation, and accountability.
  • Provide mentorship and professional development opportunities to regulatory staff.
  • Act as the primary regulatory advisor to the leadership team, providing guidance on risk management and compliance.



3. Regulatory Submissions and Approvals

  • Oversee the preparation, submission, and maintenance of regulatory dossiers.
  • Ensure timely guidance and approval while managing regulatory interactions and inspections.
  • Advocate for streamlined regulatory pathways by engaging with regulators and industry groups.



4.Compliance Oversight

  • Ensure that our equipment's meet the required regulatory standards as set by CDSCO.
  • Oversee the implementation of risk management frameworks, including adherence to ISO 13485 and knowledge of SaMD products which must comply with IEC 62304 (Software Lifecycle Processes) and ISO 14971 (Risk Management).
  • Lead regulatory responses to audits, inspections, and post-market surveillance requirements.



5. Cross-functional Collaboration

  • Partner with Govt affairs, Quality, Business Areas, Marketing and Legal team to integrate regulatory requirements.
  • Provide regular updates and input to ensure compliance with applicable standards.
  • Support with strategies by aligning regulatory timelines with market goals.

The Successful Applicant

Qualifications

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, 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

This role offers the opportunity to drive impactful healthcare solutions by partnering with top medical institutions and leveraging cutting-edge technology. The role provides a dynamic, growth-oriented environment where strategic thinking and relationship-building directly contribute to improving patient care and advancing medical innovation

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
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.