Regulatory Affairs Associate - Medical Device Labeling & QA

Akkodis; Santa Clara (CA); On-site; USD 58,000 - 62,000; Full time

Job summary

Akkodis is seeking a Regulatory Affairs Associate in Santa Clara, CA. The role requires a minimum of four years in a regulated industry and expertise in labeling, regulatory compliance, and documentation practices.

The position involves SAP MD proficiency and close collaboration across QA, engineering, and regulatory teams. The successful candidate will monitor global regulatory changes, ensure labeling compliance, and drive quality system improvements, with duties including audit support and

Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field.
• Minimum 4 years of experience in a regulated industry with related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering and/or regulatory.
• Experience working with policies and procedures impacting documentation and documentation practices.
• Proven experience in labeling design and development from a regulatory perspective.
• Strong knowledge of regulatory requirements for medical device labeling.
• Proficiency in SAP MD and other relevant software systems.
• Excellent communication and collaboration skills.
• Detail-oriented with strong organizational skills.
• Good people relations, able to work independently with good administrative and time management skills. PC and Microsoft Office experience.

Responsibilities

• Monitor regulatory changes worldwide and translate requirements into quality system updates.
• Ensure labeling activities comply with internal procedures and regulatory requirements.
• Stay updated on regulatory changes and implement updates to internal procedures.
• Drive quality system process improvements (e.g., change management).
• Maintain records of labeling changes and approvals.
• Track labeling change requests for multiple projects.
• Provide documentation and support for audits.
• Develop KPI dashboards and monitor RA internal metrics.

Skills

Regulatory Affairs

Labeling design

Documentation control

Regulatory compliance

Microsoft Office

Education

Bachelor's degree in Regulatory Affairs

Bachelor's degree in Biomedical Engineering

Tools

SAP MD

Job description

Akkodis is seeking a Regulatory Affairs Associate in Santa Clara, CA. The role requires a minimum of four years in a regulated industry and expertise in labeling, regulatory compliance, and documentation practices.

The position involves SAP MD proficiency and close collaboration across QA, engineering, and regulatory teams. The successful candidate will monitor global regulatory changes, ensure labeling compliance, and drive quality system improvements, with duties including audit support and