Compliance Specialist

JobDiva, Inc.; Sunnyvale (CA); On-site; USD 85,000 - 130,000; Full time

Job summary

Fives DyAG Corp. in Sunnyvale, CA seeks a Compliance Specialist to support quality and regulatory activities in the medical device field, interpreting global regulations and aiding the QMS.

You will participate in CAPA and corrective actions, internal/external audits, and cross-functional collaboration with Quality, Regulatory Affairs, Engineering, and Manufacturing to ensure regulatory readiness and continuous improvement.

Qualifications

• 2–3+ years of experience in quality, compliance, regulatory affairs, or related function in medical device industry.
• Strong understanding of QMS and medical device quality processes.
• Bachelor's degree in engineering, Physical Science, Biological Science, Life Sciences, or a related technical field.

Responsibilities

• Support development, implementation, and maintenance of quality and regulatory compliance processes.
• Interpret applicable medical device regulations and provide guidance to teams.
• Assist with CAPA, audit readiness, and continuous improvement activities.
• Collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations to ensure compliance.

Education

Bachelor's degree in engineering or related technical field

Equivalent combination of education, training, and relevant experience

Job description

Job Summary

The Compliance Specialist will support quality and regulatory compliance activities within the medical device industry. This role will interpret and apply applicable global regulations and standards, support the Quality Management System (QMS), and provide compliance guidance to cross-functional teams. The position will also contribute to CAPA and corrective action activities, regulatory readiness, and continuous improvement initiatives while collaborating with quality, engineering, regulatory, and manufacturing teams across multiple sites.

Roles and Responsibilities

• Support the development, implementation, and maintenance of quality and regulatory compliance processes within the organization.
• Interpret applicable medical device regulations, standards, and regulatory requirements and provide guidance to business and quality teams.
• Support compliance with EU MDR, ISO 13485:2016, MDSAP, 21 CFR Part 820, Health Canada, and other applicable international requirements.
• Participate in the maintenance and continuous improvement of the Quality Management System (QMS).
• Support CAPA, corrective action, and preventive action activities, including investigation, documentation, tracking, and effectiveness verification.
• Assist with internal and external audit readiness and follow-up activities.
• Review quality and compliance processes, procedures, and documentation for alignment with applicable requirements.
• Identify potential compliance gaps and work with relevant stakeholders to develop and implement appropriate corrective actions.
• Collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, Operations, and other cross-functional teams.
• Partner with cross-plant and global teams to support consistent implementation of compliance requirements.
• Assist with compliance-related projects and initiatives using established project management tools and techniques.
• Track project milestones, deliverables, and action items to ensure timely completion.
• Maintain accurate and complete compliance documentation and records.
• Support regulatory and quality initiatives in a deadline-driven environment while managing multiple priorities.
• Communicate compliance requirements, project status, risks, and recommendations clearly to stakeholders.

Education & Experience

• Bachelor's degree in engineering, Physical Science, Biological Science, Life Sciences, or a related technical field.
• Equivalent combination of education, training, and relevant professional experience may be considered.

• 2–3+ years of experience in quality, compliance, regulatory affairs, or a related function within the medical device industry.
• Strong understanding of Quality Management Systems (QMS) and medical device quality processes.