Senior Regulatory Affairs Specialist

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

We’re actively seeking qualified candidates for a Senior Regulatory Affairs Specialist opportunity supporting medical device regulatory submissions and compliance.

Key Responsibilities

• Prepare, coordinate, and manage regulatory submission documentation, including 510(k) submissions and EU MDR technical documentation.
• Develop regulatory submission strategies to support product approvals and market access.
• Compile documentation for regulatory submissions, license renewals, annual registrations, audits, and inspections.
• Evaluate labeling, manufacturing, marketing, and clinical documentation for regulatory compliance.
• Monitor regulatory requirements, guidance, and changes in applicable standards.
• Collaborate cross-functionally with Engineering, Quality, Clinical, and other stakeholders to achieve regulatory objectives.
• Identify opportunities to improve regulatory processes, documentation, and tracking systems.
• Provide regulatory guidance and recommendations to support timely approvals.

Required Qualifications

• Bachelor’s degree in a scientific discipline or equivalent.
• 5–8 years of relevant regulatory affairs experience.
• Demonstrated experience developing and writing 510(k) and EU MDR submissions, including regulatory strategy.
• Experience with electrical medical devices and IEC 60601 standards.
• Strong written and verbal communication skills.
• Proven ability to work independently, take ownership of deliverables, and collaborate effectively across cross-functional teams.

Position Details

• Location: Jacksonville, FL preferred; remote candidates may be considered based on experience.
• Schedule: Full-time, 40 hours per week.
• Position Type: Contract.

If you have strong medical device regulatory affairs experience and a background in 510(k) submissions, EU MDR, and IEC 60601, we’d like to hear from you!