Regulatory Affairs Specialist

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.
• Affiliate 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.
• Affiliate with risk management files in accordance with ISO 14971, including hazard analysis, risk controls, and traceability.
• Affiliate 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.
• Affiliate with EU MDR, FDA, and international regulatory documentation requests as needed.
• Affiliate with regulatory responses, customer questionnaires, compliance letters, and technical documentation packages.
• Maintain awareness of applicable standards, regulations, and guidance documents.
• Affiliate with supplier regulatory documentation, including declarations, certificates, compliance forms, and supplier change notifications.
• Help ensure product documentation is complete, accurate, controlled, and audit-ready.

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.
• 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.