About the role
About the company:Achira Labs (http://www.achiralabs.com) is a pioneering Bangalore-based company that has developed proprietary lab-on-chip (microfluidics) platforms to perform rapid and reliable blood tests in near-patient settings. The company’s culture encourages innovation and team participation at all levels and boasts a strong track record for creating globally relevant innovative technology solutions. Achira has built India’s first microfluidics-based platform for point-of-care immunodiagnostics through in-house efforts combining diverse areas including portable electronics, microfluidics, assay development and materials chemistry. Achira’s work is backed by 24 issued international patents, multiple peer-reviewed publications, many industry collaborations and several research grants from national and international funding agencies including BIRAC, Grand Challenges Canada, ICMR, DST etc. Achira has received the National Technology Award in India for new technologies (Biotechnology) from the President of India as well as MIT Technology Review’s prestigious TR35 awards in recognition of our work. Achira is well capitalized and is supported by marquee investors including Catamaran and Cipla.
Summary of the role:This is an exciting opportunity in an innovation-focused company to work with a team taking new innovative diagnostic products to market by developing our medical device platform.
Responsibilities:● Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings.● Maintenance of Quality Management System (QMS) and Regulatory compliance documents.● Write, analyze and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents including MDR 2017, EU MDR, US FDA or CE marking.● Drafting documents regarding Clinical Evaluations required for product validation and regulatory compliance.● Participate in internal/external assessment and audits.● Reporting writing for non-conformance, corrective action and preventive actions and remediation regarding product.● Support processes for handling CAPA resulting from customer complaints/feedback.● Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.● Contribute to and participate in the review of process/product changes, labelling, claims, complaints, etc., to determine the need for any regulatory activities and to ensure compliance to Indian and International requirements.
Essential Qualifications:● Master's Degree (MSc preferably in Pharma/LifeSciences) with 2 years of Medical Device Industry / Pharma QA/RA experience.● Familiarity with regulatory requirements in major international markets MDR 2017, FDA QSR, ISO 13485.
Competencies and other requirements:● Strong written communication skills especially related to scientific/technical and regulatory affairs● Organized and detail-oriented with the storage of information and documents● Prompt with responses and ability to liaison with external stakeholders● Ability to learn quickly, work independently, and maintain professional ethics.● Ability to work in a fast-paced or rapidly changing environment.● Ability to interact with staff from multiple departments.● Demonstrated proficiency in MS Office (Excel, Word, PowerPoint) is a must.
About the company
Achira Labs is a pioneering Bangalore-based company that has developed proprietary lab-on-chip (microfluidics) platforms to perform rapid and reliable blood tests in near-patient settings. The company’s culture encourages innovation and team participation at all levels and boasts a strong track record for creating globally relevant innovative technology solutions. Achira has built India’s first microfluidics-based platform for point-of-care immunodiagnostics through in-house efforts combining diverse areas including portable electronics, microfluidics, assay development and materials chemistry. Achira’s work is backed by 24 issued international patents, multiple peer-reviewed publications, many industry collaborations and several research grants from national and international funding agencies including BIRAC, Grand Challenges Canada, ICMR, DST etc. Achira has received the National Technology Award in India for new technologies (Biotechnology) from the President of India as well as MIT Technology Review’s prestigious TR35 awards in recognition of our work. Achira is well capitalized and is supported by marquee investors including Catamaran and Cipla.