Regulatory Affairs Associate

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 62304 (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.