Regulatory Affairs & Quality Specialist (Medical Imaging Devices)

Remote from: 🌐 Anywhere
Annual salary: Undisclosed
Salary information is not provided for this position. Check our Salary Directory to estimate the average compensation for similar roles.
Department: Legal & Compliance
Employment type: Part Time,
Job posted: 22 Jun 2025
Apply before: 22 Jul 2025
Experience level: Midweight
Views / Applies: 12345 / 123

About BruntWork

BruntWork connects businesses with talented remote workers from the Philippines.

Human Resources
2021

Actively Hiring

This is a remote position.

Work Schedule: 8 AM till 12 PM Pacific

Position Summary:

We are seeking a knowledgeable and detail-oriented Regulatory Affairs & Quality Specialist to manage the regulatory lifecycle of Class IIa medical devices. These software-based or integrated systems interface with imaging modalities such as CT, MRI, and Ultrasound, ensuring the appropriate storage, routing, and access of diagnostic medical images. This role ensures compliance across product development, registration, and post-market phases under EU MDR, FDA, and ISO 13485 frameworks.

Key Responsibilities:

Regulatory Affairs

Prepare and maintain regulatory submissions including EU MDR Technical Files and FDA 510(k) applications.
Ensure compliance with regulatory standards: EU MDR (2017/745), 21 CFR 820, 21 CFR Part 11, ISO 13485, IEC 62304 (software lifecycle), and ISO 14971 (risk management).
Collaborate with product, engineering, and clinical teams to define and document intended use, clinical benefits, and performance claims.
Evaluate and document software changes using MDCG guidelines for significant change assessment.
Monitor evolving regulations including AI/ML in medical software, DICOM interoperability, and cybersecurity.
Interface with Notified Bodies and Competent Authorities during audits and regulatory reviews.
Support post-market surveillance activities including vigilance reporting and periodic safety updates.
Maintain documentation and control of all regulatory files within the QMS.

Quality Assurance

Support and maintain ISO 13485-compliant Quality Management Systems.
Manage documentation, CAPAs, internal audits, and audit readiness.
Use electronic QMS tools (e.g., ComplianceQuest) to track nonconformance, training, and document control.
Collaborate cross-functionally to ensure effective quality processes.
Support external audits (Notified Bodies, FDA) and drive continuous improvement initiatives.

Qualifications:

Required

Bachelor’s degree in Engineering, Life Sciences, or Regulatory Affairs.
3+ years of experience in regulatory affairs within the medical device industry (ideally involving imaging systems, PACS, or diagnostic software).
Strong knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304.
Proven experience with Technical File development and regulatory body communication.
Excellent written and verbal communication skills.

Preferred

Experience with PACS, RIS, or vendor-neutral archives.
Familiarity with DICOM, HL7, cybersecurity in medical software.
Knowledge of FDA requirements for software-based medical devices.
RAC certification (EU or U.S.).

Independent Contractor Perks

HMO Coverage for eligible locations
Permanent work from home
Immediate hiring
Steady freelance job

ZR_24432_JOB

Annual salary information is not provided for this position. Explore salary ranges for similar roles in our Salary Directory ›

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FAQ

What position is BruntWork hiring for?

BruntWork is hiring a remote Regulatory Affairs & Quality Specialist (Medical Imaging Devices) from 🌐 Anywhere

What type of employment does BruntWork offer?

This is a Part Time role.

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