Regulatory Affairs Specialist

Broadata Communications, Inc.

Torrance (CA)

On-site

USD 120,000 - 150,000

Full time

14 days+

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Benefits offered by this job

Medical, vision and dental insurance

401(k) with company match

Flexible Spending Account

Paid vacation and holidays

Group life insurance

Job summary

Broadata Communications, Inc. in Torrance, CA is seeking a Regulatory Affairs Specialist who will support medical device compliance activities and regulatory documentation. The ideal candidate should possess 8-10 years of experience in Regulatory Affairs, with specific expertise in Class I medical devices and FDA regulations.

This full-time position requires strong communication and collaboration skills, along with a commitment to excellence in a high-tech manufacturing environment. Benefits include a competitive salary range of $120k - $150k, medical and dental insurance, and generous paid time off.

Qualifications

8-10 years of experience in Regulatory Affairs within a medical device environment.
Hands-on experience with Class I medical devices required.
Working knowledge of FDA 21 CFR Part 820 and ISO 13485.

Responsibilities

Support regulatory compliance activities for medical device products.
Maintain regulatory documentation for Class I medical devices.
Assist with Design History Files and regulatory evidence packages.

Skills

Attention to detail

Regulatory compliance knowledge

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

Microsoft Excel

QT9

NetSuite

eQMS/ERP systems

Job description

Company Overview

Broadata Communications, Inc. (BCI) is a privately held California-based corporation located in Torrance, CA. BCI is a leading and innovative company specializing in the development of market‑driven products that transmit digital multimedia (video, audio, and data) over fiber. Our clients include world leaders across 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.

On‑site position.

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. Veterans welcome! This critical, hands‑on role is based in Torrance, CA. This is NOT a remote or hybrid position.

Key Responsibilities

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.

Education & Experience

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 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

Skills & Abilities

Excellent organizational skills and strong attention to detail
Proactive and capable of managing multiple priorities while adapting to changing business needs
Effective communication and collaboration skills across departments
Comfortable working in a fast‑paced, cross‑functional team environment, working extended hours (as needed)
Strong self‑motivation and attitude for personal career growth, willingness to self‑learn, and work in new technology domains
Proficient in Microsoft Excel and working knowledge of Microsoft Office Suite

Physical Job Requirements

The employee in the position will be required to occasionally move throughout the facilities, including climbing stairs, when necessary. Occasional bending and reaching in an office environment, including opening and closing file cabinets drawers with light grasping. Type on a standard keyboard (laptop or desktop). Use standard computer display screens. Use standard push‑button phones and must speak clearly and be understood by others. Sit or stand in a standard upright position for a minimum of one hour, but up to 12 hours a day. Be able to lift and carry weight unassisted not exceeding 50 lbs.

Compensation And Benefits