Global Regulatory Affairs Specialist-Impactful Med Devices

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

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