Regualtory Affairs Specialist

EPM Scientific; Charlotte (NC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

EPM Scientific in Charlotte, NC is seeking a Regulatory Affairs Specialist to help shape regulatory strategy and ensure global product registrations across markets. You will collaborate with Quality, R&D, Operations and Commercial teams to support submissions and lifecycle activities.

The role covers regulatory compliance, labeling review, and interaction with regulatory authorities. Strong knowledge of FDA regulations and international requirements is essential, with 3+ years of relevant

Qualifications

• Bachelor's degree or equivalent experience in a regulated field.
• 3+ years of Regulatory Affairs experience within Medical Devices, Pharmaceuticals, Combination Products, or a related regulated industry.
• Strong knowledge of FDA regulations and international regulatory requirements.
• Experience supporting product registrations, submissions, compliance activities, or technical documentation.

Responsibilities

• Supporting global regulatory submissions, registrations, renewals, and product lifecycle activities.
• Reviewing product changes and assessing regulatory impact across domestic and international markets.
• Maintaining technical documentation and regulatory records.
• Supporting compliance activities related to FDA, EU MDR, and international regulatory requirements.
• Reviewing labeling, training materials, and promotional content.
• Managing regulatory databases, product registrations, and government documentation requests.
• Acting as a regulatory partner to cross-functional teams during product development and change management activities.
• Supporting audits, inspections, distributor relationships, and regulatory authority interactions.

Skills

Regulatory knowledge

Communication skills

Cross-functional

FDA regulations

Education

Bachelor's degree

Tools

Regulatory databases

Job description

Medical Device / Pharma | Hybrid Opportunity | Competitive Salary + Benefits

Are you a Regulatory Affairs professional looking for an opportunity to make a real impact on innovative products that improve patient outcomes?

A growing healthcare organisation is seeking a Regulatory Affairs Specialist to join its expanding team. This role offers the chance to work across both regulatory compliance and submissions, supporting products distributed in global markets and partnering closely with Quality, R&D, Operations, and Commercial teams.

This is an excellent opportunity for experienced Regulatory Affairs Specialists, with strong regulatory exposure who are looking for a broader regulatory-focused position.

The Opportunity

You'll play a key role in developing and executing regulatory strategies, maintaining global product registrations, and ensuring ongoing compliance across international markets.

Key responsibilities include:

• Supporting global regulatory submissions, registrations, renewals, and product lifecycle activities.
• Reviewing product changes and assessing regulatory impact across domestic and international markets.
• Maintaining technical documentation and regulatory records.
• Supporting compliance activities related to FDA, EU MDR, and international regulatory requirements.
• Reviewing labelling, training materials, and promotional content.
• Managing regulatory databases, product registrations, and government documentation requests.
• Acting as a regulatory partner to cross-functional teams during product development and change management activities.
• Supporting audits, inspections, distributor relationships, and regulatory authority interactions.

What We're Looking For

• Bachelor's degree or equivalent experience.
• 3+ years of Regulatory Affairs experience within Medical Devices, Pharmaceuticals, Combination Products, or a related regulated industry.
• Strong knowledge of FDA regulations and international regulatory requirements.
• Experience supporting product registrations, submissions, compliance activities, or technical documentation.
• Familiarity with EU MDR, ISO standards, and global regulatory frameworks.
• Strong communication skills and the ability to influence cross‑functional stakeholders.
• Experience interacting with regulatory authorities is highly desirable.

Ideal Backgrounds

We welcome applications from professionals with experience in:

• Regulatory Affairs
• Quality Assurance & Regulatory Affairs
• Quality Management with regulatory ownership
• Compliance & Regulatory Leadership
• Medical Devices
• Pharmaceuticals
• Combination Products
• Diagnostics or Healthcare Products

Why Apply?

• Join a company developing products that address unmet patient needs.
• Influence global regulatory strategy and product approvals.
• Broad exposure across regulatory submissions, compliance, and lifecycle management.
• Collaborative environment with strong cross‑functional visibility.
• Excellent opportunity for career progression within Regulatory Affairs leadership.

If you're looking for a role where you can expand your regulatory expertise, work on meaningful healthcare products, and contribute to global market access, we'd love to hear from you.