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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