QAra Executive

**QARA Executive (Quality Assurance & Regulatory Affairs)** **About Prayasta** Founded in 2017 in Bangalore, Prayasta operates on the principle of tailoring implants to individuals rather than requiring individuals to conform to standardized implant sizes. In pursuit of this vision, Prayasta has pioneered the world's first 3D printer capable of producing "implant-grade" silicone, facilitating the creation of a diverse array of soft-tissue implants. Prayasta has received support through various grants, including those from the Department of Science & Technology (DST), Biotechnology Industry Research Assistance Council (BIRAC), Ministry of MSME (MoMSME), Ministry of Electronics and Information Technology (MEITY), Start-up Karnataka, and the National Research Development Corporation (NRDC). The company has also earned acclaim, being honored with the National Start-up Technology Award 2022 from the Technology Development Board (TDB) and securing patents in both India and the USA for its pioneering technology. Comprising a dynamic and motivated team of engineers, scientists, and entrepreneurs, Prayasta is dedicated to developing globally outstanding products that make a positive impact on society. **Summary** **Key Responsibilities**: - Support the implementation and maintenance of the Quality Management System (QMS) as per ISO 13485 and relevant regulatory requirements. - Assist in conducting internal audits, supplier audits, and audit readiness for external inspections (e.g., FDA, Notified Bodies). - Participate in root cause analysis, non-conformance reporting (NCR), and Corrective and Preventive Actions (CAPA). - Manage documentation control, SOPs, batch records, and quality logs in compliance with QMS standards. - Coordinate training sessions and maintain training records related to quality and regulatory processes. - Assist in compiling and maintaining regulatory submissions (e.g., 510(k), CE technical files, country-specific registrations). - Ensure ongoing compliance with applicable global regulatory requirements (FDA, EU MDR, etc.). - Monitor and communicate regulatory changes and support impact assessments on products and processes. - Help prepare Product Dossiers, Risk Management files, and Clinical Evaluation Reports. - Support product labelling, UDI requirements, and post-market surveillance activities. - Maintain organized filing systems—both physical and digital. - Order and track office supplies, equipment, and inventory. - Schedule meetings, manage calendars, and support general office coordination. - Assist in preparing reports, letters, and internal communications. - Support HR and admin tasks such as onboarding documentation and leave tracking. - Record and process invoices, payments, and expense claims. - Assist with bank reconciliations, petty cash handling, and ledger maintenance. - Support month-end and year-end financial processes. - Coordinate with vendors and clients for payment follow-ups. - Maintain accurate and up-to-date financial records and documentation. **Qualifications**: - Education: Graduate degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field. Additional training in Quality or Regulatory Affairs is an advantage. - Experience: Minimum 1-3 years of experience in a Quality Assurance and/or Regulatory Affairs role, preferably in the medical device or healthcare industry. - Standards & Compliance: Working knowledge of ISO 13485, 21 CFR Part 820, and EU MDR. Familiarity with ISO 14971 for risk management is a plus. - Documentation: Experience in handling QMS documentation, including SOPs, CAPAs, internal audits, and regulatory submissions such as CE technical files or 510(k)s. - Software Skills: Proficient in Microsoft Office Suite (Word, Excel, PowerPoint). Experience with electronic QMS tools or document control systems is a strong advantage. - Regulatory Knowledge: Understanding of global regulatory requirements and ability to support registration and compliance activities for different markets (e.g., US, EU, India). - Communication: Strong verbal and written communication skills with the ability to prepare clear reports, documentation, and correspondence for regulatory bodies and internal teams. - Attention to Detail: High level of accuracy in handling technical documents, data entries, and compliance records. - Professionalism & Initiative: Organized, self-driven, and capable of handling tasks independently while working effectively in a cross-functional team. **Desired Qualifications**: - Diploma or degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field. - 1-3 years of experience in a Quality Assurance and/or Regulatory Affairs role, preferably in the medical device or healthcare industry. - Working knowledge of ISO 13485, 21 CFR Part 820, and EU MDR regulatory requirements. - Proficiency in Microsoft Office, especially Excel and Word; experience with QMS or document control software is an advantage. - Excellent att