Regulatory Affairs Specialist

Regulatory Affairs Specialist

Broadata Communications, Inc. (BCI) – Torrance, CA

On-site.

Broadata Communications, Inc. (BCI) is a privately held California-based corporation. BCI is a leading and innovative company specializing in the development of market-driven products for the transmission of digital multimedia (video, audio, and data) over fiber. Our clients are world leaders in their industries, spanning entertainment, broadcast, medical, professional audio/video, house of worship, education, government, military, and transportation sectors. We are ISO 13485 and ISO 9001 certified, with a strong commitment to quality, innovation, and continuous improvement.

Broadata Communications, Inc. is seeking a Regulatory Affairs Specialist to support the company’s medical device compliance activities, regulatory documentation, and quality system requirements. This role will support Class I and Class II medical device programs, including technical documentation, design history files, change control, risk management, supplier documentation, labeling review, customer regulatory requests, and audit readiness.

The ideal candidate has hands‑on experience working in an FDA‑regulated and ISO 13485 environment, with a strong understanding of Class I medical device requirements. Experience with Class II medical devices, 510(k) support, IEC 60601‑1, EU MDR technical documentation, or customer-driven regulatory submissions is highly preferred.

This is an excellent opportunity for a detail‑driven professional who thrives in a high‑tech manufacturing environment and values teamwork, accountability, and continuous improvement. This critical, hands‑on role is based in Torrance, CA. We offer a fast‑paced, high impact and stimulating work environment with opportunities for professional growth and development within BCI. Veterans welcome! This is a hands‑on position. This is NOT a remote or hybrid position.

• Support regulatory compliance activities for medical device products manufactured or supported by Broadata.
• Maintain and update regulatory documentation for Class I medical devices; support Class II documentation where applicable.
• Assist with Design History Files, Device Master Records, Technical Files, and regulatory evidence packages.
• Support FDA 21 CFR Part 820 / QMSR transition activities, ISO 13485 compliance, and customer‑specific regulatory requirements.
• Review and approve product labeling, IFUs, specifications, drawings, procedures, and quality records for regulatory compliance.
• Support risk management files in accordance with ISO 14971, including hazard analysis, risk controls, and traceability.
• Assist with change control assessments to determine regulatory impact.
• Support internal audits, external audits, customer audits, and certification body audits.
• Work cross‑functionally with Quality, Engineering, Manufacturing, Supply Chain, and Program Management to ensure regulatory requirements are understood and implemented.
• Support EU MDR, FDA, and international regulatory documentation requests as needed.
• Assist in preparing regulatory responses, customer questionnaires, compliance letters, and technical documentation packages.
• Maintain awareness of applicable standards, regulations, and guidance documents.
• Support supplier regulatory documentation, including declarations, certificates, compliance forms, and supplier change notifications.
• Help ensure product documentation is complete, accurate, controlled, and audit‑ready.

Job responsibilities within our organization are dynamic. This may not be a complete list of duties. Other responsibilities and duties may be assigned by your supervisor or upper management.

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline.
• Minimum 8‑10 years of experience in Regulatory Affairs, Quality Assurance, or Compliance within a medical device environment.
• Hands‑on experience with Class I medical devices required.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device documentation requirements.
• Experience supporting technical documentation, DHF/DMR files,…