Job summary
Job post source
This job is from a recruiting firm hiring for a separate company, as indicated by the company name GForce Life Sciences which is known for staffing services and the description focusing on a contract role.
Job overview
The Regulatory Labelling Specialist role involves managing and developing compliant product labeling to meet FDA and international standards, impacting regulatory compliance and product market readiness.
Responsibilities and impact
The specialist will design and develop product labeling, manage labeling projects with tight deadlines, coordinate reviews and approvals, submit UAL packages in SAP, monitor regulatory updates, and maintain documentation to support audits.
Experience and skills
The position requires a bachelor's degree in Regulatory Affairs, Biomedical Engineering, or related field, with over 4 years of experience in regulated industries focusing on labeling or documentation, and proficiency in SAP, Adobe Acrobat Pro, and Microsoft Office.
Job location and travel
The job is onsite in Santa Clara, CA, indicating a physical office environment.
Unique job features
The role is a 12-month contract, which may offer unique project experience and exposure to regulatory processes in a dynamic environment.
Company overview
GForce Life Sciences is a consulting firm specializing in providing life sciences companies with expert solutions in regulatory compliance, clinical operations, and quality assurance. They generate revenue by offering tailored consulting services to pharmaceutical, biotechnology, and medical device companies, ensuring these organizations meet industry standards and regulatory requirements. Founded with a mission to bridge the gap between scientific innovation and regulatory approval, GForce Life Sciences has built a reputation for delivering strategic insights and operational excellence. Their team of seasoned professionals brings extensive industry experience, making them a trusted partner in navigating the complexities of the life sciences sector.
How to land this job
Tailor your resume to emphasize your experience in regulatory labeling, specifically highlighting your skills in designing product labels and managing labeling projects under tight deadlines, as these are key responsibilities at GForce Life Sciences.
Highlight your familiarity with FDA and international regulatory requirements, as well as your proficiency with SAP, Adobe Acrobat Pro, and Microsoft Office to align with the job's technical demands.
Apply through multiple platforms including the GForce Life Sciences corporate careers page and LinkedIn to maximize your application visibility for this Regulatory Labelling Specialist role.
Connect on LinkedIn with current Regulatory Affairs professionals or team members at GForce Life Sciences, using ice breakers like commenting on recent regulatory changes they’ve shared or asking about their experience managing labeling projects.
Optimize your resume for ATS by incorporating keywords from the job description such as 'regulatory labeling,' 'FDA compliance,' 'SAP,' 'labeling documentation,' and 'medical device labeling regulations' to ensure it passes initial screenings.
Leverage Jennie Johnson's Power Apply feature to automate tailored applications, identify the best channels for submission, and find relevant LinkedIn contacts, freeing you to focus your energy on preparing for interviews and further networking.
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