Regulatory Affairs Associate

5 days ago

Bengaluru Chennai Mysuru, India Larsen & Toubro (L&T) Full time

JOB TITLE:

Medical Device Regulatory Compliance Specialist

JOB SUMMARY:

We are seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to play a critical role in ensuring our medical device development processes meet the highest standards of quality and regulatory compliance. The ideal candidate will have hands-on experience with technical documentation, quality systems, and regulatory submissions, and will play a key role in ensuring product safety and compliance throughout the development lifecycle, specifically focusing on the Design History File (DHF) and Device Master Record (DMR).

RESPONSIBILITIES:

  • Support the preparation and maintenance of USFDA and EU MDR-compliant technical documentation for Class II / Class III devices.
  • Evaluate the effectiveness of risk analysis processes, design input and output documentation, verification and validation activities, design reviews, Software documentation per IEC as applicable), design transfer, and design change processes.
  • Support creation and maintenance of Design History Files (DHF), Device Master Records (DMR)
  • Participate in design reviews and ensure regulatory inputs are incorporated into development documentation.
  • Ensure traceability of design inputs, outputs, verification, and validation activities.
  • Collaborate with internal and client teams to align documentation with regulatory expectations.
  • Maintain documentation in accordance with ISO 13485 and client-specific QMS requirements.
  • Track and implement updates based on evolving EU MDR guidance and standards.
  • Identify and document all identified gaps and non-conformances.

QUALIFICATIONS:

  • Bachelor's degree in a relevant scientific, medical, or engineering discipline.
  • Proven experience in medical device regulatory compliance.
  • Knowledge of FDA 21 CFR and EUMDR regulations.
  • Hands on experience ISO standards related with cardiovascular standards, Biocompatibility (implantable) and related safety and performance standards
  • Strong understanding of DHF and DMR requirements.
  • Experience with Technical documentation for Class II / Class III devices
  • Excellent analytical, problem-solving, and documentation skills.
  • Ability to work independently and as part of a team.
  • Strong communication and interpersonal skills.

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