Remote Regulatory Specialist II — Medical Devices

EXALTA; United States; On-site; USD 110,000 - 170,000; Full time

Job summary

EXALTA is seeking a Subject Matter Expert in global medical device and quality system regulations to lead regulatory strategy, planning, and submissions. You will assess product design, manufacturing, labeling, and quality system changes for regulatory impact and author essential change assessments to ensure compliant labeling, advertising, and product claims.

You will collaborate with R&D, operations, quality, and clinical teams to secure regulatory clearances across MDSAP, EU, UK, and other

Qualifications

• Bachelor’s degree in a scientific or technical discipline with 3+ years of relevant experience; 5+ years may suffice without degree.
• RAC certification(s) a plus.

Responsibilities

• Provides regulatory strategy and planning across global markets.
• Author and submit regulatory applications for medical devices.
• Assess design, manufacturing, labeling and quality system changes for regulatory impact.
• Develop change impact assessments and ensure labeling accuracy with global regulations.
• Maintain regulatory documents, procedures, and forms; train staff as needed.
• Coordinate with cross-functional teams to ensure project success.
• Engage with regulatory agencies and partners to secure clearances.
• Support audits and continuous improvement of the quality system.

Skills

Regulatory knowledge

Medical terminology

Quality systems

Regulatory liaison

Project management

Documentation

Education

Bachelor’s degree in scientific/technical discipline

RAC certification

Job description

EXALTA is seeking a Subject Matter Expert in global medical device and quality system regulations to lead regulatory strategy, planning, and submissions. You will assess product design, manufacturing, labeling, and quality system changes for regulatory impact and author essential change assessments to ensure compliant labeling, advertising, and product claims.

You will collaborate with R&D, operations, quality, and clinical teams to secure regulatory clearances across MDSAP, EU, UK, and other