Regulatory Affairs and Quality Assurance Specialist

Role Overview

This role involves supporting regulatory research to facilitate the approval of investigational products, drafting and reviewing regulatory submissions, and maintaining detailed Regulatory Chronological Files. Responsibilities also include anticipating and managing future regulatory and quality requirements for clients with minimal supervision.

Key Duties and Responsibilities

• Analyze client documentation to create precise regulatory submissions to the FDA and other regulatory bodies within agreed timelines and adhering to relevant federal laws, including but not limited to Q-Submission Requests, 510(k) submissions, De Novo Classification Requests, Premarket Approval Applications, CE Mark certifications, IDE and IND applications, ANDAs, amendments, supplements, annual reports, and 505(b)(2) and 505(b)(1) submissions.
• Conduct regulatory research and develop strategic assessments for client products, identifying expected regulatory classification and outlining necessary analytical and clinical testing requirements.
• Participate in meetings with regulatory agencies, documenting meeting minutes and capturing feedback accurately.
• Manage regulatory documentation and ensure regulatory timelines, budgets, and scopes are monitored and adhered to for client deliverables and FDA submissions.
• Contribute content expertise for blog posts, articles, and assist in Business Development activities such as presenting at conferences, webinars, or information sessions as required.
• Draft and update Standard Operating Procedures (SOPs), forms, work instructions, templates, and plans to ensure regulatory and quality compliance.
• Support the training and adoption of SOPs including preparing training materials.
• Manage quality documentation for client projects, becoming proficient with client quality management system (QMS) software.
• Participate in and support internal client audits, supplier evaluations, and audits, assist with Corrective and Preventative Actions (CAPAs).
• Effectively communicate complex regulatory requirements and strategies to team members and external clients.
• Tackle complex projects requiring comprehensive analysis and interpretation of regulatory guidelines.
• Monitor and coordinate follow-ups on outstanding agency queries and related actions.
• Maintain current knowledge on FDA regulations, guidelines, international harmonization documents, and approved products to provide informed recommendations for projects.
• Supervise and review work carried out by Regulatory Associates as needed to meet project deadlines.

Qualifications and Skills Required

• Bachelor’s degree or an equivalent qualification.
• At least 2 years of experience in Regulatory Affairs relating to medical devices, pharmaceuticals, and biologics, or demonstrated proficiency as assessed by management.
• Fundamental understanding of federal regulations (21 CFR) related to medical devices and drugs, including product approval, listing requirements, regulatory maintenance, and FDA inspections.