• Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management. • Lead regulatory activities for clinical development programs, including new IND submissions, protocol amendments, annual reports, safety updates, and global CTA maintenance. • Partner with Clinical Development, Nonclinical, CMC, and Translational teams to align regulatory strategy with evolving development objectives and timelines. • Prepare and manage regulatory submissions (e.g., IND amendments, new INDs, CTAs, briefing packages) in collaboration with internal stakeholders and external vendors. • Contribute to preparation for and participation in health authority interactions (e.g., FDA, EMA, MHRA), including meeting strategy, briefing document preparation, and response coordination. • Provide regulatory guidance to cross-functional teams on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities. • Support planning for future marketing applications by ensuring development programs are conducted in alignment with global registration requirements. • Monitor and interpret evolving regulatory guidance and communicate potential impact on ongoing programs. • Contribute to regulatory intelligence efforts and continuous improvement of regulatory processes.

About ABC Legal Services: ABC Legal Service is proud to be the national leader in service of process. We are a team of 1000 and growing with offices in Los Angeles, Oklahoma City, Phoenix, Brooklyn, Chicago, Washington DC, and more. Seattle is our home and headquarters. We’ve been successful in this unique business for over 30 years and we continue to advance our technology and business processes to remain years ahead of what our competition is able to offer. Our focus is to expand our technology lead, acquire and integrate less efficient competitors, and tap into new segments through an integrated inbound marketing and sales approach. Job Overview: The Lead role at ABC Legal serves as the entry-level management position, guiding individuals, small team, or project involving direct reports. Leads are responsible for ensuring their team members understand and meet their own objectives. This role requires the ability to manage day-to-day operations, manage employee timecards/scheduling, provide feedback, train employees, conduct and deliver employee reviews, and serve as a point of contact between staff and higher management. Leads may also participate in hiring process for their team and recommend disciplinary actions when necessary. Key Responsibilities: - Train and provide guidance to new hires and team members on e-filing procedures - Resolve issues with filings (can involve calling and emailing courts, e-filing portals, account managers, other individuals within the company) - Track daily team metrics in a spreadsheet and maintain spreadsheet functionality - Create and maintain documents describing standard e-filing procedures - Assist efiling managers with assigning work, setting daily team goals, calculating KPIs, and lead daily team huddle. Qualifications: - 6 months relevant experience in e-filing a plus - High school diploma or GED required - E-Filing experience working with multiple states preferred - Detail-oriented and a quick learner - Experience and basic proficiency with Microsoft Office; Intermediate Excel skills preferred - Basic coding and computer programing skills a plus - Typing speed of at least 70 wpm We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. Join our team today! Benefits: - Health, Dental, Vision insurance - 401(k) with company matching - Paid time off - 7 Paid company holidays - 4 Floating holidays per-year - Life Insurance and AD&D Insurance - Long Term Disability - Health Care Reimbursement Flexible Spending Account - Dependent Care Flexible Spending Account - EAP (Employee Assistance Program) - Pet Insurance Salary Range: $43,000 - $53,000 per year, depending on various factors which include, but are not limited to location, education, skills, experience and performance.

Role Description Under the general direction of the Regulatory Affairs Director, the Regulatory Affairs Specialist will be responsible for participating in regulatory activities, preparing regulatory filings, and supporting registrations and strategies for domestic and key international regions (OUS). - Provides high-quality support and assistance in areas related to regulatory strategy, product classification, and submissions to introduce new or changed medical devices and radio equipment to markets worldwide for Teladoc Health, Inc. - Assists with identifying applicable regulations, guidance documents, and standards for medical devices and radio equipment. - Prepares, reviews and files, as appropriate, FDA Annual Reports on Radiation Safety, EU technical documentation, Canada Medical Device Establishment Licenses, and no-file justifications. - Ensures consistency, completeness, and accuracy in regulatory documentation and adherence to regulations, applicable guidelines, and the Quality Management System. - Drives development and updates to regulatory affairs procedures, work instructions, and templates to improve operations or reflect changing regulatory requirements in collaboration with stakeholders and in line with the Quality Management System. - Conducts reviews of promotional and advertising material for compliance with standards and regulatory requirements. Assists with labeling development and reviews. - Conducts regulatory research and data collection to inform regulatory strategy and submissions. Understands, investigates, and evaluates regulatory history of products for context. - Supports FDA, notified body and other regulatory body inspections and audits, as needed. - Works in close collaboration with stakeholders and internal partners to achieve business objectives. - Maintains ongoing surveillance on the changing regulatory landscape, including domestic and international radio equipment and medical device regulations and guidance documents. - Reviews Engineering Change Requests to ensure compliance with regulatory standards and Quality Management System requirements. Qualifications - BS/BA or equivalent with 3-6 years of experience of working in an FDA or ISO regulated environment. - Familiar with industry standards and regulations (e.g. 21 CFR 820, ISO 13485, and ISO 14971). - Be able to identify missing information and evaluate accuracy of the presented information. - Demonstrates strong attention to detail; monitors own work to ensure quality. - Listens and gets clarification; responds well to questions; understands nuances related to documentation, and customer matters. - Writes clearly and informatively; varies writing style to meet needs; able to read and interpret written information. - Follows policies and procedures; supports organization's goals and values. - Proficient in Microsoft Office (Outlook, Word, Excel, and Power Point), Adobe Acrobat, and Social Media web platforms. Benefits - Enjoy an inclusive benefits program centered around you and your family, with tailored programs that address your unique needs.

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. • Demonstrates diligence in protecting the confidentiality of each subject/patient. • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. • For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes Conducts Source Document Review of appropriate site source documents and medical records. • Verifies required clinical data entered in the case report form (CRF) is accurate and complete. • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. • Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture. • Verifies site compliance with electronic data capture requirements. • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. • Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. • Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.