Regulatory Affairs Associate

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 Regulatory Affairs Associate role in Santa Clara CA 95054. Ideally, looking for someone with Minimum 4 years of experience in a regulated industry and experience in related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering and/or regulatory.

Rate Range: $42/hour to $45/hour on w2. The rate may be negotiable based on experience, education, geographic location, and other factors.

JOB RESPONSIBILITIES:

• Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system.
• Ensure all labeling activities comply with internal procedures and regulatory requirements.
• Stay updated on changes in regulatory requirements and implement necessary updates to internal procedures.
• Driving quality system process improvement initiatives (e.g. change management).
• Maintain accurate records of labeling changes and approvals.
• Track labeling change requests for multiple projects.
• Provide documentation and support for audits.
• Driving preparation of KPI dashboards and maintaining a pulse on formal RA internal metrics.

QUALIFICATIONS:

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field.
• Minimum 4 years of experience in a regulated industry and experience in 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.

If you have questions about the position, please contact Mohammed Irfan Murtuza at [e-mail]

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

The California Fair Chance Act

Los Angeles City Fair Chance Ordinance

Los Angeles County Fair Chance Ordinance for Employers