Medical Device Compliance Engineer

Company: Willware Technologies

Role: Medical Device Compliance Engineer

Experience: 7+ Years

Location: Bangalore

Work Mode: Onsite


Job Summary

We are looking for an experienced Medical Device Standards Compliance Engineer to ensure that medical devices meet international safety and regulatory requirements. The candidate will be responsible for managing product compliance with global standards, coordinating with external certification laboratories, and preparing regulatory documentation for product approvals.

Key Responsibilities

• Lead compliance activities related to IEC 60601-1 and related collateral standards for medical devices.

• Work closely with external safety testing labs and notified bodies such as UL, TV, ETL, DQS, and LNE to obtain product approvals and certifications.

• Ensure products comply with European Union Medical Device Regulation requirements.

• Prepare and maintain regulatory documentation including Technical Files, STED, and GSPR for CE marking.

• Support the product development team by providing compliance guidance during design and development phases.

• Coordinate testing activities and resolve compliance issues identified during certification testing.

• Maintain accurate documentation for regulatory submissions and product approvals.

• Stay updated with changes in medical device regulations, standards, and certification requirements.

Required Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Electrical Engineering, Electronics Engineering, or related field.

• Minimum 7+ years of experience in medical device standards compliance or regulatory engineering.

• Strong knowledge of IEC 60601 standards and medical device safety requirements.

• Hands-on experience with EU MDR and CE marking process.

• Experience working with notified bodies and external certification laboratories.

• Experience preparing technical documentation for regulatory approvals.