Job Description
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
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
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