<div>ABOUT THE COMPANY<br /> Wrig Nanosystems is a rapidly growing medical device start-up with focus on cutting edge<br /> bioelectronics based medical diagnostics. We focus on developing advanced intellectual<br /> properties and their derived products.<br /> The company has been awarded by the Government of India as the &quot;Indian Medical Device<br /> Company of the Year&quot; in the year 2021.The company has a series of new globally advanced<br /> technologies in the pipeline and is progressing towards becoming a global giant in<br /> personalized diagnostics.</div> <div><br /> Detailed view of our product and vision can be accessed at https://truehb.com/</div> <div>&nbsp;</div> <div>Job Summary and Responsibilities:</div> <div><br /> Job Summary:</div> <div><br /> We are seeking an experienced Regulatory Affairs Specialist to oversee regulatory<br /> compliance for medical devices, combination products, and procedure packs. The ideal<br /> candidate will have expertise in global regulatory submissions, compliance with<br /> international standards, and project management.</div> <div><br /> Key Responsibilities:</div> <div><br />  Manage regulatory submissions for medical devices and in-vitro medical devices.<br />  Lead regulatory projects, ensuring coordination with internal teams, notified bodies,<br /> and regulatory authorities.</div> <div> Prepare applications for new medical device licenses, post-approval changes, and<br /> timely renewals in compliance with EU-MDR/IVDR, IMDR, HSA, and ASEAN Medical<br /> Device Directives.<br />  Ensure compliance with international standards such as ISO 13485, ISO 14971, ISO<br /> 10993, IEC 62366, IEC 62304, ISO 15223, ISO 20417, and ISO 60601.<br />  Apply for NCC, MSC, and FSC for both manufactured and imported products.<br />  Support the tender team in bid submissions and GEM Portal processes.<br />  Handle regulatory activities related to export and post-approval changes.<br />  Oversee artwork preparation and revisions in compliance with EU-MDR/IVDR,<br /> USFDA, IMDR, ISO 20417, ISO 18113 and ISO 15223 requirements.<br />  Conduct internal audits to ensure compliance with company policies and regulatory<br /> standards, while also managing external audits, including ISO 13485.<br />  Respond to regulatory queries from notified bodies (BSI, TUV, DNV) and other<br /> regulatory authorities.<br />  Maintain a strong understanding of medical device regulations and quality<br /> management system requirements.<br />  Stay up to date with industry trends, emerging regulations, and regulatory strategies.</div> <div>&nbsp;</div> <div>QUALIFICATIONS AND EXPERIENCE REQUIRED</div> <div><br /> Technical Skills:</div> <div><br />  Extensive experience in regulatory affairs within the device industry.<br /> Behavioural Skills<br /> 1) Leadership,<br /> 2) Self-start-up,<br /> 3) Team player,<br /> 4) Analytical problem-solving skill,<br /> 5) Learning orientation,<br /> 6) Creative and capable to work in a challenging environment.</div> <div>Preferred Experience<br /> Minimum 2 years of experience in Medical Devices/Invitro Medical Devices<br /> Should have knowledge of USFDA and EUMDR</div>