Regulatory Affairs & Quality Engineer - Medical Device

Company Description

Bioscan Research is a company based in Ahmedabad, dedicated to improving patient outcomes for traumatic brain injury through the use of a machine learning-powered NIRS device, CEREBO. The company aims to achieve early detection of brain injuries at a pre-symptomatic phase, ultimately enhancing patient care and treatment outcomes.

Role Summary

The Regulatory Affairs Engineer / Associate will support and coordinate Quality Management System (ISO 13485) activities, Design Controls and Risk Management (ISO 14971), and regulatory submissions (FDA, CE) for the company's medical device products. This role is execution- and coordination-focused and works closely with senior management, project managers, documentation specialists, engineering teams, and external regulatory consultants.

Key Responsibilities

I. Quality Management System (ISO 13485)

• Support implementation, maintenance, and continuous improvement of the ISO 13485 Quality Management System.
• Assist in drafting, updating, and maintaining SOPs, templates, and quality records.
• Coordinate QMS activities across R&D, production, clinical, regulatory, and commercial teams.
• Support training coordination and training record maintenance.
• Assist in preparation for internal, certification, surveillance, customer, and regulatory audits.
• Support Management Review activities, including data collection and reporting.

II. Design Controls & Risk Management (ISO 14971)

• Maintain structured Design History Files (DHF) across multiple projects
• Support implementation and maintenance of design controls and lifecycle documentation.
• Maintain Risk Management Files in accordance with ISO 14971
• Assist in preparing and maintaining risk registers, FMEA, and hazard analyses under guidance.
• Ensure end-to-end traceability between requirements, risks, risk controls, and verification evidence.

III. Regulatory Submissions (FDA, CE)

• Support regulatory pathway activities (FDA 510(k), CE MDR)
• Coordinate compilation and organisation of regulatory submission documents.
• Track submission milestones, timelines, and deliverables.
• Coordinate inputs from engineering, clinical, manufacturing, and external test laboratories.
• Support responses to regulatory queries and deficiency letters.
• Ensure submission documentation aligns with internal QMS and design intent.

IV. Documentation & Cross-Functional Coordination

• Work closely with the internal team to ensure: Document control and version management, Timely updates to SOPs, DHF, and regulatory records, Completeness and consistency of audit- and submission-ready documentation
• Participate in cross-functional project, design, and review meetings.
• Track audit observations, non-conformances, and improvement actions.
• Promote awareness of quality, regulatory, and documentation requirements across teams.

Qualifications, Experience and Attribute Requirement

• Bachelor's degree in Engineering, Biomedical, Biotechnology, Life Sciences, or a related field.
• 2–3 years of experience in medical device Quality and/or Regulatory Affairs.
• Hands-on experience in Design Controls, Risk Management and ISO 13485.
• Exposure to FDA 510(k) and/or CE MDR submissions is preferred.
• Experience supporting audits is an advantage.
• Strong documentation discipline and attention to detail.
• Strong coordination, follow-up, and organisational skills.
• Clear written and verbal communication.
• Willingness to learn and grow in a fast-paced MedTech environment.