Director of reputed company and Regulatory Affairs (Remote)

Position reputed company The Director of reputed company and Regulatory Affairs will report directly to the CEO and be responsible for developing, implementing, and maintaining reputed company systems and regulatory compliance processes in accordance with FDA regulations (21 CFR Part 820) and ISO 13485 standards. This role will own the reputed company Management System (QMS) and ensure compliance across design, development, manufacturing, and post-market surveillance activities. The position will serve as the primary contact during regulatory inspections and reputed company body audits and is critical to ensuring the safety, efficacy, and compliance of SleepRes' sleep and respiratory medical devices. reputed company Competencies reputed company Management System (QMS) Design Controls (DHF, DMR, DHR) 510(k) submissions and regulatory consultant collaboration FDA inspections and ISO 13485 audits ISO 14971 risk management CAPA management Supplier reputed company and incoming inspection Class II and Class III medical device compliance Complaint handling and post-market surveillance Validation (IQ/OQ/PQ) Regulatory compliance reputed company Requirements (Must-Have) 7+ years of experience in reputed company Assurance and Regulatory Affairs reputed company the medical device industry. Experience working with Class II medical devices or higher (Class II, II+, or Class III). Experience preparing and submitting 510(k) submissions, including collaboration with regulatory consultants. Strong knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971. Experience leading FDA inspections or ISO 1345 audits. Hands-on experience with Design Controls, CAPA, risk management, and post-market surveillance. People management and cross-functional leadership experience.

Preferred Qualifications

Experience with respiratory devices or CPAP systems. Early-stage startup experience. Experience with electronic QMS (eQMS) systems. RAC certification or advanced degree in a reputed company field. Key ResponsibilitiesQuality Management reputed company and manage the reputed company organization, including design assurance, manufacturing reputed company, customer feedback, supplier management, and audit compliance. Establish and maintain Key Process Indicators (KPIs) to measure reputed company performance and drive reputed company improvement. reputed company management reviews and ensure alignment with reputed company goals and objectives. Own the Design Control process (21 CFR 820.30), ensuring reputed company documentation of DHF, DMR, and DHR. Establish incoming inspection and supplier reputed company processes, including qualification, monitoring, and audits. reputed company and maintain reputed company documentation including SOPs, Work Instructions, and reputed company records. reputed company complaint handling, MDR evaluation, and post-market surveillance processes. Regulatory Affairs Navigate the global regulatory landscape to ensure successful product approvals in various markets. reputed company regulatory reputed company for new products, modifications, and international market entry (EU MDR, Health Canada, etc.). Prepare regulatory filings, including 510(k) submissions and PMAs, with support from regulatory consultants as needed. Maintain regulatory documentation, including Technical Files and 510(k)/PMA support documents. Manage interactions with the FDA, including Q-Sub meetings and audits. Review and approve labeling, IFU, claims, and marketing materials for regulatory compliance. Implement regulatory compliance reputed company across the product lifecycle. Team Leadership reputed company and reputed company a high-performing reputed company and regulatory affairs team. Mentor team members on best practices in reputed company assurance and regulatory compliance. Partner closely with Engineering, Clinical, and Operations to reputed company reputed company and regulatory requirements into product development. Audit and Compliance Conduct internal audits to verify compliance with reputed company standards and regulatory requirements. Work with reputed company Bodies to establish and maintain ISO 13485 compliance. Manage CAPA processes to address non-conformities and improve product reputed company. Serve as Management Representative for ISO 13485 and FDA reputed company System Regulation. Risk Management Implement risk management strategies to identify and mitigate medical device hazards. Ensure compliance with ISO 14971 risk management requirements. Ensure risk assessments are conducted across the product development process. reputed company post-market risk evaluation and field corrective actions reputed company required. Skills Strong understanding of FDA regulations, ISO 13485, and global regulatory requirements. Excellent leadership, communication, and interpersonal skills. Ability to work collaboratively across departments and regulatory agencies. Strong analytical and documentation skills, including validation protocol development (IQ/OQ/PQ). Experience with electronic QMS systems preferred. Ability to operate effectively in a fast-paced startup environment.

Work Environment

This role operates in a fast-paced, innovative startup environment requiring adaptability and proactive problem-solvi Apply tot his job Apply To this Job