Job Description : Chief Clinical Officer

One of the Analytix Company 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, 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

- Develop a global network of Key-Opinion-Leaders to influence adoption of novel diagnostic solutions developed

- 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 (bachelors, masters, 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

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