Description

Job Summary:

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.

• 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, change control, labeling review, and audit preparation.
• Strong attention to detail and ability to manage documentation in a controlled QMS environment.
• Ability to work cross-functionally with Engineering, Quality, Operations, and external customers.
• Strong written and verbal communication skills.
• Ability to organize regulatory information clearly and respond to customer or auditor requests in a professional manner.
• Experience with Class II medical devices is strongly preferred.
• Experience supporting 510(k), FDA submissions, EU MDR technical files, or international registrations preferred.
• Familiarity with IEC 60601-1, IEC 62304, IEC 62366, ISO 14971, and electrical medical device requirements preferred.
• Experience in a contract manufacturing or complex electromechanical manufacturing environment preferred.
• Experience with customer audits from large medical device OEMs preferred.
• Experience with QT9, NetSuite, Master Control, Greenlight Guru, Arena, or similar eQMS/ERP systems preferred.
• RAC certification or regulatory affairs coursework preferred but not required.

Job Type & Location

This is a Permanent position based out of Torrance, CA.