Regulatory Affairs Operations Specialist

Virtual Company; Sunnyvale (CA); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Life insurance

Disability insurance

Job summary

The Fountain Group in Sunnyvale is seeking a Regulatory Labeling Specialist to design, revise, and implement international medical device labeling, including IFUs and country-specific labeling, ensuring compliance with FDA and global requirements.

You will independently manage multiple labeling projects, coordinate redline reviews, approvals, and labeling releases while supporting centralized international labeling processes and collaborating with Regulatory Affairs, Quality, Packaging, and

Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or related field is required.
• 4+ years of experience in Regulatory Affairs, regulatory compliance, quality, or related operations within a regulated industry is required.
• Hands-on experience developing, revising, and implementing regulatory labeling, including labeling changes, redlines, and approval workflows, is required.
• Strong knowledge of medical device labeling regulations, including FDA and international regulatory requirements, is required.
• Experience with change control, regulatory documentation, and quality system procedures is required.
• Direct experience with medical device labeling, including IFUs, import labels, and country-specific labeling, is preferred.
• Experience independently managing multiple labeling projects and coordinating with cross-functional regulatory, quality, and packaging teams is preferred.
• Experience with SAP/SAP MD, Adobe Acrobat Pro, and document management systems is preferred.

Responsibilities

• Designing, developing, revising, and implementing international medical device labeling to ensure compliance with FDA and international requirements.
• Manage multiple post-approval labeling change projects, coordinating reviews, approvals, and labeling releases.
• Collaborate with Regulatory Affairs, Quality, Packaging, and Labeling teams to assess regulatory changes and drive process improvements.

Skills

Regulatory labeling

Regulatory compliance

Project coordination

Cross-functional collaboration

Education

Bachelor's degree in Regulatory Affairs or Biomedical Engineering

Tools

SAP/SAP MD

Adobe Acrobat Pro

Document management systems

Job description

About this Client:

• A leading global healthcare and medical device organization specializing in innovative technologies that improve patient outcomes and advance the treatment of complex cardiovascular conditions.
• This opportunity supports an established vascular medical device division, offering exposure to international regulatory operations, global labeling initiatives, and cross-functional projects that directly impact product compliance across worldwide markets.

Position Details:

• Shift: Monday-Friday, Standard Business Hours 8:00 am - 5:00 pm PST, Onsite Position!
• Pay: Range starts at $40-45/hr!
• Duration: 12+ Month contract
• Contract: W2 contract with a possibility of extension or conversion beyond the original duration based on performance & budget at that time.
• Benefits: After 90 days of employment you will be eligible for our company provided benefits which include Health, vision, dental, life and disability insurance! Inquire for more details on these.

What you will be doing:

• Position is primarily responsible for designing, developing, revising, and implementing international medical device labeling, including Instructions for Use (IFUs), product labels, import labels, and country-specific labeling to ensure compliance with FDA and international regulatory requirements.
• Position will be in charge of independently managing multiple post-approval labeling change projects, coordinating redline reviews, approval workflows, documentation packages, and labeling releases while supporting the centralization of international labeling processes.
• Position will also be responsible for collaborating with Regulatory Affairs, Quality, Packaging, and Labeling teams to assess regulatory changes, resolve labeling issues, maintain accurate change control records, support audits, and drive process improvements across the medical device portfolio.

What we are looking for:

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field is required!
• 4+ years of experience in Regulatory Affairs, regulatory compliance, quality, or related operations within a regulated industry is required!
• Hands-on experience developing, revising, and implementing regulatory labeling, including labeling changes, redlines, and approval workflows, is required!
• Strong knowledge of medical device labeling regulations, including FDA and international regulatory requirements, is required!
• Experience with change control, regulatory documentation, and quality system procedures is required!
• Direct experience with medical device labeling, including IFUs, import labels, and country-specific labeling, is preferred!
• Experience independently managing multiple labeling projects and coordinating with cross-functional regulatory, quality, and packaging teams is preferred!
• Experience with SAP/SAP MD, Adobe Acrobat Pro, and document management systems is preferred!

Additional Details on applying:

• Candidates requiring visa sponsorship, including H-1B visa holders, as well as those interested in C2C arrangements, are welcome to inquire.
• Candidates open to relocating are also encouraged to apply; however, relocation expenses would be the candidate’s responsibility.

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