Regulatory Affairs Lead – Medical Device Labeling (Contract)

Generis Tek Inc; California; On-site; USD 55,000 - 69,000; Full time

Job summary

Generis Tek Inc. in Santa Clara, CA seeks a Regulatory Affairs Associate to design, develop, and implement international addendum labeling for medical devices.

You will liaise with global RA experts and US RA owners to ensure labeling meets regulatory requirements, including FDA standards, country-specific labeling, and import labeling. The role focuses on leading labeling change projects, coordinating cross-functional reviews, and driving process improvements within a regulated environment.

Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field.
• Minimum 4 years in a regulated industry and experience in related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering and/or regulatory.
• 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.

Responsibilities

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

Skills

Troubleshooting

Critical thinker

Problem resolution

Time management

Education

Bachelor's degree in Regulatory Affairs or related field

Tools

SAP MD

Adobe Acrobat Pro

Job description

Generis Tek Inc. in Santa Clara, CA seeks a Regulatory Affairs Associate to design, develop, and implement international addendum labeling for medical devices.

You will liaise with global RA experts and US RA owners to ensure labeling meets regulatory requirements, including FDA standards, country-specific labeling, and import labeling. The role focuses on leading labeling change projects, coordinating cross-functional reviews, and driving process improvements within a regulated environment.