Regulatory Affairs Associate

Planet Pharma Group; 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

Description / Summary: We are seeking a highly skilled and experienced Regulatory Affairs Operations Specialist to join our Regulatory Affairs Operations team. The position will be responsible for designing, developing, and implementing international addendum labeling (IFUs, import labels, country-specific labeling) that meets international requirements for our medical devices. This role requires background in regulatory affairs and experience with labeling from a regulatory perspective. The individual will be responsible for liaising with international RA local experts and US RA product owners as key stakeholders.

Key Responsibilities

This role will introduce a new process to centralize post-approval addendum labeling activities for the full Vascular medical device portfolio.

Initiatives include but are not limited to:

Label Design and Development

• Collaborate with Regulatory Affairs specialists, international regulatory affiliates, and labeling project management to develop labeling strategies.
• Create and design addendum labeling including Instructions for Use (IFUs), product labels, import labels, and country-specific labeling.
• Fulfill international addendum labeling requests, ensuring conformance with international country requirements, country of origin, and international certification marks.
• Ensure all labeling complies with regulatory requirements and standards.
• Effectively work with cross-functional team to develop labeling that meets the requirements of the FDA and international regulatory agencies, internal brand/design requirements, and product specifications.
• Independently manage large-scale labeling change projects.
• Communicate labeling projects and priorities across the division, plan project timelines which may involve managing multiple, concurrent deadlines.
• Complete assessments for projects to identify scope and impact to labeling.
• Understand impact of changing regulations and product requirements regarding labeling.

Labeling Implementation

• Fill out forms, coordinate redlines review and submit labeling packages to the labeling team for development.
• Coordinate labeling release with Regulatory Affairs specialists, international regulatory affiliates, and the Packaging, Labeling, and Program Management (PLPM) team.
• Prepare and submit Universal Addendum Labeling (UAL) SAP package to PLPM team to program addendum labeling.
• Troubleshoot issues, communicate impact, and propose solutions.

Regulatory Affairs / Regulatory Intelligence

• 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).

Documentation and Reporting

• 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.

Preferred Qualifications

• Experience with medical device labeling or labeling for highly regulated industry and international regulatory requirements.
• Familiarity with Adobe Acrobat Pro, SAP, and other content management systems.
• Substantial experience coordinating and executing project activities in a highly regulated industry.

Skills

• Independent
• Troubleshooting
• Critical thinker
• Ability to drive a problem through resolution and implement mitigations
• Ability to handle multiple streams simultaneously

Pay ranges between 38-41/hr based on experience