Senior Medical Device Regulatory Affairs Specialist (Remote)

Intepros; Jacksonville (FL); On-site; USD 110,000 - 160,000; Full time

Job summary

Intepros is seeking a Senior Regulatory Affairs Specialist to lead medical device regulatory submissions and ensure compliance across US and EU markets. The role focuses on 510(k) submissions and EU MDR, with IEC 60601 integration and cross-functional coordination.

You will develop submission strategies, prepare documentation for licenses, renewals, audits, and inspections, and mentor teams to navigate regulatory changes.

Qualifications

• 5–8 years of regulatory affairs experience.
• Experience with 510(k) and EU MDR submissions.
• Experience with IEC 60601 standards.

Responsibilities

• Prepare and manage regulatory submission documentation.
• Develop regulatory submission strategies for approvals.
• Coordinate documentation for renewals, audits, and inspections.
• Evaluate labeling and manufacturing for compliance.
• Collaborate cross-functionally with Engineering, Quality, Clinical.

Skills

Regulatory submissions

510(k) knowledge

EU MDR

IEC 60601

Regulatory strategy

Technical writing

Cross-functional work

Independent worker

Education

Bachelor’s degree in science

Job description

Intepros is seeking a Senior Regulatory Affairs Specialist to lead medical device regulatory submissions and ensure compliance across US and EU markets. The role focuses on 510(k) submissions and EU MDR, with IEC 60601 integration and cross-functional coordination.

You will develop submission strategies, prepare documentation for licenses, renewals, audits, and inspections, and mentor teams to navigate regulatory changes.