Head - Regulatory Affairs | Medical Devices | Bangalore

About Our Client

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

Job Description

• Regulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals.
• Leadership and Team Management- Build and lead a high-performing regulatory team, fostering a culture of excellence, innovation, and accountability.
• Regulatory Submissions and Approvals- Oversee the preparation, submission, and maintenance of regulatory dossiers.
• Compliance Oversight- Ensure that the equipments meet the required regulatory standards as set by CDSCO.
• 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 (, MBA, 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 (, 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