Regulatory Affairs Specialist

Regulatory Affairs Specialist

Broadata Communications, Inc. (BCI) 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!

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:

• Salary Range: $120k - $150k (based on experience and qualifications)
• Medical, vision and dental insurance
• 401(k) with company match (100% of the first 4% in eligible compensation)
• Flexible Spending Account
• 2 weeks paid vacation
• 1 Week sick pay
• 10 company holidays
• Group life insurance