Regulatory Affairs Specialist

Job Overview

Regulatory Affairs Specialist roles in Charlotte, NC sit at the center of product development and compliance. You're the person who makes sure everything lines up with the rules; FDA guidelines, international standards, state level requirements. It's not a static job. Regulations shift, and you have to shift with them. You'll spend time reading proposed rules, preparing submissions, and advising teams on what the law actually means for their work. These positions typically exist within medtech, pharma, biotech, or consumer goods companies. The work is detail heavy but strategic. You aren't just checking boxes; you're protecting the company's ability to operate and sell.

Duties & Responsibilities / JobXi / Charlotte, NC

• Prepare and submit regulatory filings. Depending on the sector, that means 510(k)s, PMAs, INDs, NDAs, or something else. You handle the paperwork from start to finish.
• Track changing regulations. Agencies publish new guidance often. You digest it, summarize what matters, and tell internal teams what they need to change.
• Review product labels and marketing claims. One wrong phrase could trigger a warning letter. You catch those before anything goes public.
• Work with cross functional teams. You'll sit in on R&D meetings. You'll push back on timelines when the regulatory path isn't clear. You're the bridge between compliance and product development.
• Audit documentation and records. This isn't glamorous, but it's essential. You verify that files match what was submitted and what was approved.
• Manage communication with regulatory agencies. That means responding to questions, participating in meetings, and sometimes negotiating timelines.

Requirements / JobXi / Charlotte, NC

• Education: A Bachelor's degree is the baseline. Life sciences, engineering, or a related field is typical. A Master's or PhD helps, especially for more technical roles.
• Experience: 2 5 years in regulatory affairs, quality assurance, or a closely related area. Some employers want direct submission experience. Others are open to strong candidates from R&D or QA who understand the regulatory framework.
• Skills: You need to read dense documents and pick out what matters. You write clearly and concisely. You're comfortable with ambiguity; sometimes the regulation doesn't say exactly what to do, and you have to make a judgment call.
• Certifications: RAC (Regulatory Affairs Certification) is common and valued. Not always required, but it gives you an edge.
• Mental demands: High attention to detail for long stretches. You're juggling multiple submissions with different deadlines. The ability to prioritize under pressure matters.

What It's Like in This Role / JobXi / Charlotte, NC

You're not sitting in a silo. In Charlotte, NC, regulatory teams tend to be integrated within broader product groups. That means you'll attend project kickoffs, get pulled into design reviews, and field questions from marketing. The pace varies. Some weeks are steady; reviewing documents, updating files. Other weeks are frantic, with a submission deadline looming and last minute changes coming from engineering. You'll likely use document management systems, like Veeva or MasterControl, and spend significant time in Microsoft Office. Remote and hybrid setups are common, but you may need to be onsite for audits or key meetings. The workload is real, but it's cyclical. It comes in waves.

Why You'll Like This Opportunity

Regulatory is a field where experience compounds. Every submission you handle becomes something you can point to later. The role offers genuine mobility; you can move into more senior regulatory positions, shift into quality systems, or pivot to government affairs. You're not stuck. Many employers in Charlotte, NC offer flexible scheduling, and the work itself gives you deep knowledge of how products actually come to market. That kind of insight is hard to replicate in other roles.

Schedule & Work Type

Most positions are full time. Some employers offer contract or contract to hire arrangements. Remote, hybrid, and onsite options all exist; it depends on the company and the specific team's culture. Standard business hours are the norm, but deadline crunches may require extra time.

How to Apply

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Disclaimer

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Equal Opportunity

All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, or veteran status.