Global Regulatory Labeling Specialist – Medical Devices

Planet Pharma; Santa Clara (CA); On-site; USD 52,000 - 56,000; Full time

Job summary

Planet Pharma is seeking a Regulatory Affairs Operations Specialist in California to design, develop, and implement international addendum labeling for medical devices. You will liaise with international RA experts and US product owners to ensure labeling meets global requirements and standards.

You will lead label design and implementation projects, coordinate cross-functional teams, manage timelines, and maintain documentation for audits, while staying current with evolving regulatory rules

Qualifications

• Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, or related field.
• Minimum 4 years in a regulated industry and related operations areas.
• Experience with labeling from a regulatory perspective.
• Strong knowledge of regulatory requirements for medical device labeling.

Responsibilities

• Design, develop, and implement international addendum labeling (IFUs, import labels, country-specific labeling).
• Collaborate with RA specialists and international affiliates to develop labeling strategies.
• Manage large-scale labeling change projects and timelines across concurrent deadlines.
• Prepare and submit labeling packages and coordinate releases with PLPM team.
• Monitor regulatory changes and update internal procedures accordingly.
• Maintain records of labeling changes and support audits.

Skills

Independent

Troubleshooting

Critical thinking

Problem resolution

Multi-tasking

Education

Bachelor’s degree in Regulatory Affairs or related field

Tools

SAP MD

Adobe Acrobat Pro

CMS

Job description

Planet Pharma is seeking a Regulatory Affairs Operations Specialist in California to design, develop, and implement international addendum labeling for medical devices. You will liaise with international RA experts and US product owners to ensure labeling meets global requirements and standards.

You will lead label design and implementation projects, coordinate cross-functional teams, manage timelines, and maintain documentation for audits, while staying current with evolving regulatory rules