Head - Regulatory Affairs | Medical Devices | Bangalore
3 days ago
Drive regulatory strategy with global impact at a leading healthtech innovatorLeadership role with strong visibility and growth potentialAbout Our ClientThis opportunity is with a global MNC recognized for its contributions to the life sciences industry.Job DescriptionRegulatory 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 ApplicantEducation: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
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Bangalore Division, India Michael Page Full timeDrive 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 Regulatory Strategy Development- Define and drive the regulatory vision and strategy...
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Quality & Regulatory Lead- Medical Devices
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
1 week ago
bangalore, India NexorTest Technologies Full timeLocation: Bengaluru / Hybrid Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role Summary: The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working...
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Regulatory Affairs Specialist
1 week ago
Bangalore, India NexorTest Technologies Full timeLocation: Bengaluru / Hybrid Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role Summary: The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working...
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Regulatory Affairs Analyst
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