Quality and Regulatory Affairs Associate

Job Description

Job Title: Quality and Regulatory Affairs Associate Department: Quality and Regulatory Affairs Reports To: Technical Project Lead (Mechanical Design & QMS Control) Position Purpose: The Quality and Regulatory Affairs Specialist supports the execution and maintenance of Wosler’s Quality Management System (QMS) and assists in the preparation of regulatory documentation for Class II medical device submissions. This role exists to ensure that all design, development, and quality activities are properly documented and compliant with applicable regulatory requirements. The position provides hands-on support in preparing, reviewing, and organizing controlled documents, risk management files, and design records under the supervision of the Technical Project Lead. The role contributes to maintaining Wosler’s compliance with ISO 13485, MDSAP, and 21 CFR Part 820 within a lean, remote team environment. Duties and Responsibilities: 1. Regulatory Documentation Support - Assist in compiling and formatting regulatory submissions (e.g., FDA 510(k), Health Canada Class II License) under direction of the Technical Project Lead. - Prepare supporting documentation such as Device Descriptions, Indications for Use, and labeling summaries as delegated. - Participate in reviews of regulatory deliverables to verify completeness and consistency. - Track document versions and ensure submission components align with approved templates and quality system procedures. 2. Quality Management System (QMS) Documentation - Maintain and update controlled documents within the QMS in accordance with applicable SOPs and document control processes. - Participate in scheduled reviews of assigned procedures, forms, and records to ensure accuracy and currency. - Support internal audit preparation, CAPA documentation, and management review inputs as delegated. - Ensure document and record organization supports audit readiness and traceability requirements. 3. Design and Risk Documentation - Support the creation and maintenance of Design History File (DHF), Device Master Record (DMR), and Risk Management - File (RMF) components throughout the product lifecycle. - Assist with verification and validation (V&V) documentation, including traceability matrices and design review records. - Ensure changes to design documentation are properly recorded and controlled in accordance with QMS procedures. 4. Compliance and Standards Support - Apply principles of ISO 14971 risk management and design control under supervision. - Contribute to documentation supporting software lifecycle or safety testing (e.g., IEC 62304, IEC 60601-1) as assigned. - Participate in data collection and evidence preparation for regulatory audits or inspections. 5. Team Collaboration - Collaborate closely with engineering, manufacturing, and quality personnel to ensure documentation accuracy and regulatory alignment. - Communicate clearly and proactively within the team regarding document status, review needs, or identified gaps. - Support other quality and regulatory activities as assigned by the Technical Project Lead. Qualifications 1. Education: - Bachelor’s degree in Biomedical Engineering, Quality Engineering, Life Sciences, or a related technical discipline. 2. Specialized Knowledge: - Foundational understanding of ISO 13485:2016, 21 CFR Part 820, and MDSAP framework. - Familiarity with regulatory pathways for Class II medical devices (FDA 510(k), Health Canada). - Awareness of design control, risk management, and verification documentation principles. 3. Skills and Attributes: - Excellent organizational and documentation skills with attention to detail. - Clear written and verbal communication skills across remote teams. - Proficiency in standard productivity tools (e.g., bolthires Workspace, project management software, and quality management software). - Demonstrated ability to learn new regulatory and quality processes quickly. 4. Abilities: - Manage multiple documentation tasks and meet defined deadlines with limited supervision. - Apply QMS procedures accurately and consistently. - Maintain confidentiality and data integrity in controlled documentation environments. - Professional Certifications / Experience Requirements: - Formal training and proof of certification in Quality or Regulatory Affairs or comprehensive equivalent experience with documented evidence. - ISO 13485 Internal auditor certification or prior audit participation is considered an asset. 5. Experience: - Minimum 1–3 years in a medical device, diagnostics, or related regulated industry. - Experience contributing to regulatory submissions or QMS documentation preferred. Working Conditions - Fully remote position, operating within standard weekday hours. - Requires frequent use of computer systems for document preparation and virtual collaboration. - Occasional extended hours may be required during submission or audit preparation cycles. 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