Regulatory Affairs Specialist

Regulatory Affairs Level III (Senior Specialist)

Peyton Resource Group provided pay range

This range is provided by Peyton Resource Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$99,000.00 / yr - $118,000.00 / yr

Job Summary :

Responsible for global product registrations and regulatory compliance across the design, manufacturing, and commercialization of medical devices, including Class I & II devices, software as a medical device (SaMD), and de novo devices. Oversees regulatory approvals, maintains compliance with applicable standards, and supports Quality Management System (QMS) initiatives to ensure product and process adherence to regulatory requirements.

Key Responsibilities

Regulatory Submissions & Compliance

• Develop and execute regulatory strategies to achieve market clearance efficiently.
• Prepare, submit, and maintain product registrations, certifications, and approvals to meet U.S., EU, and international requirements.
• Prepare 510(k) and / or De Novo submissions for FDA.
• Develop technical documentation to ensure EU MDR compliance.
• Manage international product registration activities aligned with business objectives.
• Provide regulatory input for product labeling and marketing materials.
• Monitor new and evolving regulatory requirements; communicate business impacts.
• Lead or support Corrective and Preventive Action (CAPA) activities.

Product Development Support

Change Control Management

Audits & Inspections

Qualifications

Education

Experience

Technical Skills

Personal Attributes

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Administrative, Accounting / Auditing, and Engineering

Industries

Medical Equipment Manufacturing

J-18808-Ljbffr