NIRAMAI Health Analytix is looking for a Strong Leader, Clinical Specialist and Medical Expert with an entrepreneurial mindset to spearhead company’s clinical marketing and regulatory division. Further strengthen or foster the mission of NIRAMAI that has established itself as a world class AI Healthcare organization anchored on Innovation, Compliance and Compassion.
Primary role & responsibilities:
- Spearhead strategy and planning of the regulatory and clinical function at Niramai
- Develop a global network of Key-Opinion-Leaders to influence adoption of novel diagnostic solutions developed by NIRAMAI
- Review and identify appropriate regulatory bodies and plan pre-market regulatory conformance activities
- Design and supervise the implementation of compliance and clinical activities in accordance with healthcare regulations and standards of different nations
- Provide thought leadership in the organization by keeping abreast with the latest guidelines of US FDA, CE and other regulatory bodies
- Review & supervise high quality effort for preparation of regulatory dossier to CE, US FDA, ISO 13485 and IEC
- Oversee and manage periodic internal and external audits to ensure ISO/IEC compliance
- Partner with Heads of Business, Technology, Research and Product to design regulatory, clinical and medical marketing strategies for current and future healthcare products of the company
- Plan and Conduct CMEs/ seminars to support brand marketing and business development.
- Identify & activate external partners such as key hospitals , regulatory notified bodies, external audit agencies etc to ensure timely regulatory clearances and established proof of high clinical efficacy.
- Be a spokesperson at trade association meetings, public hearings and scientific meetings, and in interactions with the US FDA
- Lead, build & manage a strong clinical operations and regulatory compliance team focused on delivering results within stipulated budget
- Build a strong clinical training function in the company (a) to ensure screening protocol conformance of technicians, (b) report certification by doctors and (c) regulatory training for employees.
Requirements for the role-
- Education – University degree in science (bachelor’s, master’s, doctorate, MBBS) – biology, biostatistics, pharmacy, pharmacology, or a related discipline
- Relevant experience of 7 – 15 years in a pharma or medical devices company
- Leader who thinks of unconventional &new avenues for evangelizing products & services, that enable wide-spread adoption
- Outstanding networking skills & ability to liaise with stakeholders/ regulatory authorities within the ecosystem
About NIRAMAI Health Analytix Pvt Ltd
NIRAMAI is a health technology startup founded in July 2016. Their key offering is a Novel Cancer Detection Solution for Hospitals, Diagnostic centers, mass screening camps and home screening too. NIRAMAI is Series A funded by reputed Indian investors such as Pi Ventures, Axilor, Ankur Capital, Binny Bansal and international investors such as Dream Incubator (Japan), BeeNext (Singapore) and 500 Startups(US). NIRAMAI has won many national and international awards and recognitions. It is the only Indian company listed on CBInsights AI 100 2019 list, the Top 100 AI companies in the world across all domains. Niramai also won the National Startup Award 2020 under the health category among the several other accolades received. For more details please visit : https://niramai.com
|Job Category||Clinical Affairs|