Director of Regulatory Affairs

ALKU

Orlando (FL)

On-site

USD 155,000 - 200,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading medical equipment firm in Orlando is looking for a Director of Regulatory Affairs to oversee the Quality Management System and ensure compliance with FDA and international standards. The ideal candidate must have over 5 years of regulatory experience with Class II medical devices, exceptional leadership skills, and a strong understanding of regulatory frameworks. This on-site role is vital to support product innovation in a fast-paced environment.

Qualifications

5+ years of hands-on regulatory and quality assurance experience with Class II medical devices.
Strong knowledge of FDA GMP/QSR, ISO 13485, and EU MDR regulations.
Proven leadership in managing quality systems in a medical device manufacturing environment.

Responsibilities

Lead and improve the Quality Management System (QMS) in alignment with regulatory requirements.
Prepare and manage Class II 510(k) submissions and technical documentation for CE marking.
Serve as the primary regulatory liaison during FDA inspections and audits.

Skills

Regulatory compliance

Quality assurance

Technical writing

Cross-functional collaboration

Problem-solving

Education

Bachelor’s degree in engineering or life sciences

Job description

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We’re seeking a proactive, experienced regulatory and quality leader to manage and enhance our Quality Management System (QMS) and global regulatory activities. This on-site role (no remote) is critical to ensuring full compliance with FDA, CE, ISO 13485, and other applicable standards while supporting fast-paced product innovation and business growth. You’ll collaborate cross-functionally with R&D, Manufacturing, and Customer Service to deliver safe, high-quality Class II medical devices to global markets.

Key Responsibilities:

Lead and continuously improve Omega’s QMS in alignment with FDA QSR, ISO 13485, and EU MDR requirements to ensure regulatory compliance and product excellence
Prepare and manage Class II 510(k) submissions, technical documentation for CE marking under EU MDR, and other international submissions as needed
Serve as the primary regulatory liaison during FDA inspections, notified body audits, and internal/external quality audits
Oversee CAPA, complaints, internal audits, employee training, and document control processes
Ensure timely reporting and escalation of adverse events and field actions in compliance with post-market surveillance requirements
Support design control and risk management activities to ensure products meet applicable regulatory requirements throughout the development lifecycle
Promote a culture of quality, accountability, and continuous improvement across the organization
Provide clear, data-driven reports on QMS performance, audit readiness, and regulatory metrics to executive leadership

Requirements:

Bachelor’s degree in engineering, life sciences, or a related technical field
5+ years of hands-on regulatory and quality assurance experience with Class II medical devices in both U.S. (510(k)) and EU (MDD/MDR CE Marking) markets
Strong understanding of FDA GMP/QSR, ISO 13485, EU MDR, 21 CFR Part 820, and IEC 62304 (preferred for devices with software components)
Demonstrated success in authoring and submitting 510(k)s, preparing EU technical documentation, and managing regulatory interactions with FDA and EU notified bodies
Proven leadership in managing quality systems in a medical device manufacturing environment
Excellent cross-functional collaboration, communication, and organizational skills