Compliance

• Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator
• Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals
• Prepares and submits regulatory information required to obtain global market access
• Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s)
• Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams
• Conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission
• Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status
• Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission
• Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials
• Assists in the development and enhancement of Regulatory Affairs processes

Senior Regulatory Affairs Program Lead – MedTech Surgery

• Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator.
• Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.
• Prepares and submits regulatory information required to obtain global market access.
• Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s).
• Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams.
• Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.
• Guide conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
• Assists in the development and enhancement of Regulatory Affairs processes.

• Conduct site reviews and investigations as requested by the Social Security Administration (SSA)
• Conduct additional reviews/investigations that DRC has determined are warranted
• Develop corrective action plans to assist representative payees to conform to requirements specified by the SSA
• Submit a report to the SSA on each completed review/investigation
• Conduct an initial onsite assessment of any organization that begins collecting a fee for its services as a representative payee to ensure that it is properly established according to SSA requirements
• Provide short-term, technical assistance and referrals to clients, callers and others, including to Social Security disability beneficiaries who have representative payees.
• Engage in community-based advocacy and community leadership, representing DRC.
• Prepare written materials and conduct outreach to, and education and training of, consumers, community groups, advocates and others, particularly those from traditionally underserved communities on issues pertaining to their rights as SSA beneficiaries and the duties of their rep payee.

Compliance Investigator

• Maintains Regulatory Affairs certifications for domestic and international customers and distributors.
• Ensures Argen uses relevant information and judgement to determine whether events or processes comply with laws, regulations, or standards.
• Reviews document changes, product labeling and in-house procedures to ensure regulatory requirements are met.
• Prepares for and facilitates internal, external, and third-party audits as necessary.
• Provides input for selecting the most effective regulatory course of action.
• Supports International Operations with foreign product registration through distributors according to each country’s regulatory requirements.
• Researches and responds to internal and external customer requests for regulatory information.
• Interprets regulatory rules or rule changes and ensures that they are communicated through corporate policies and procedures.
• Interfaces with the FDA concerning issuing Certificates to Foreign Government for The Argen Corporation and its subsidiaries as needed.
• Maintains Quality Assurance and Quality Management Certificates (ISO and CE) for The Argen Corporation and its subsidiaries interfacing with Notified Bodies.
• Maintains Declaration of Conformities for all Argen products and its subsidiaries.
• Reviews product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Accurately maintains the regulatory database to reflect all current and obsolete products.
• Communicates with the Secretary of State office, Department of State and Foreign Embassies or Consulates regarding authentication of documents to support the registration process.
• Supports product registration for Argen’s International Branches to meet foreign requirements for China, Canada, Taiwan, Korea, and others.
• Develops and generates customer-specific certificates of quality analysis and conformities to satisfy distributor and customer-specific needs.
• Completes supplier and subcontractor evaluations and approval forms for customers.
• Provides and submits regulatory documentation to notified bodies and Authorized Representative to support MDD/MDR requirements.
• Represents Regulatory Affairs and Quality team in yearly audits for quality and regulatory documentation including Technical Documentation.
• Contributes to Regulatory projects and deliverables to ensure Argen remains compliant to MDR and ISO requirements.

Regulatory Affairs Specialist

• Lead the development, maintenance, and continuous improvement of enterprise policies, standards, controls, and implementation procedures
• Translate regulatory, contractual, and cybersecurity requirements into actionable governance and control requirements
• Design, maintain, and optimize the enterprise control framework, including control rationalization, consolidation, and framework alignment activities
• Partner with cybersecurity, infrastructure, engineering, cloud, application, data governance, privacy, and compliance teams to ensure governance requirements are practical, feasible, and align with business and operational needs
• Provide subject matter expertise related to control intent, implementation expectations, regulatory interpretation, and governance best practices
• Support governance modernization initiatives, ServiceNow IRM policy management, and control automation efforts to improve scalability, consistency, and efficiency
• Develop and support control policies and strategies, prepare governance reporting, and communicate program status, priorities, and progress to stakeholders and leadership

Senior GRC Analyst

Senior Governance, Risk, & Compliance (GRC) Analyst

• Assist with the assessment of all regulatory risks and controls related to deposit and lending products
• Participate in discussions with senior management regarding risk assessments and regulatory change management
• Develop and maintain policies and standards for regulatory compliance
• Socialize compliance principles and assist with developing procedures
• Collaborate with Testing and Monitoring Teams to assess compliance with legal requirements
• Ensure material compliance issues are tracked and reported
• Coordinate with Regulatory Change Management to implement new regulations
• Communicate compliance analysis and reporting to oversight committees

Senior Compliance Advisory Manager – Lending & Deposits

• Support the design and implementation of scalable, repeatable compliance and risk assessment workflows, including intake, escalation, documentation, and follow-up.
• Implement and maintain a broad range of compliance policies and procedures
• Proactively monitor and research relevant laws, regulations, and industry standards elevant to the fintech industry and the regulated sectors our clients operate in, including AI, data privacy, KYC/AML and international expansion, to continuously refine processes as the regulatory landscape evolves
• Conduct compliance risk assessments and audits
• Develop and deliver compliance training programs to employees to reinforce a strong culture of compliance and understanding of relevant regulations and internal policies
• Identify and implement opportunities to leverage AI and automation tools to streamline compliance tracking and reduce manual overhead
• Partner closely with cross-functional teams, including Product, Engineering, Sales, and Legal, so that compliance considerations are seamlessly integrated into all aspects of the business lifecycle
• Build dashboards and prepare recurring reports for leadership on program health and key initiatives.
• Collaborate with legal team members to update privacy policies, contractual terms, and data processing agreements as needed

Compliance Analyst

• Own and strengthen our controls environment, ensuring compliance requirements are effectively implemented and maintained.
• Support and mature our GRC program, including SOC 2 operations and alignment with broader security frameworks such as NIST.
• Build and maintain our Business Continuity and Disaster Recovery program, including BIAs, continuity plans, and recovery runbooks.
• Conduct vendor and third-party risk assessments as we expand our global network of partners.
• Support MiCA licensing and U.S. Money Transmitter License applications through due diligence, regulatory responses, and compliance reporting.
• Manage the security issue lifecycle, driving remediation efforts and partnering with teams to reduce risk.
• Help standardize policies, controls, and compliance processes that can scale across jurisdictions and regulatory frameworks.

GRC Analyst

• Lead and support the integration of Boeing Quality Management System (QMS) principles into engineering capability team processes
• Apply knowledge of AS9100D and QMS standards to assess process maturity and identify improvement opportunities
• Lead and participate in process reviews and internal checks to ensure that audit readiness and quality standards are effectively embedded
• Lead the analysis of process performance trends, develop metrics, and evaluate the effectiveness of engineering KPIs for compliance efforts
• Lead the development and documentation of process enhancements/plans and optimization strategies to address complex challenges within engineering programs and capabilities
• Conduct benchmarking and advanced analyses to assess and improve process capability and standardization across teams
• Collaborate with cross-functional stakeholders, support leadership reviews, and facilitate workshops focused on compliance, process enhancement, and resolving recurring issues
• Prepare executive-level reports and presentations to communicate progress, findings, and planned initiatives across engineering quality and compliance efforts
• Ability to travel up to 10% of the time

Compliance and Quality Process Engineer – Experienced/Senior Level

• Design, build, and evolve end-to-end GRC automation across risk, compliance, policy, and issue management domains — including writing and maintaining Python-based automation scripts, services, and tools.
• Integrate GRC workflows with source systems via RESTful APIs, webhooks, and event-driven integration patterns.
• Architect and maintain a systems integration layer connecting GRC platforms to enterprise data sources, enabling real-time risk signal ingestion and automated control validation.
• Partner with Cyber Risk leadership to operationalize quantitative and scenario-based risk analysis.
• Engineer automated pipelines for ingesting threat, vulnerability, asset, and business context data.
• Translate regulatory and framework requirements into automated, testable, and traceable controls.
• Implement continuous control monitoring and evidence refresh to support ISO, SOX, SOC, and regulatory audits.
• Design, build, and deploy Agentic automation solutions — autonomous AI-driven agents capable of reasoning across GRC data.
• Own the end-to-end systems integration architecture connecting GRC platforms to security tools, cloud environments, HR systems, asset management, and third-party risk platforms.

Principal, GRC Automation, Cyber Risk

• Develop and maintain software applications.
• Collaborate with cross-functional teams to deliver high-quality software.
• Participate in code reviews and contribute to technical architecture decisions.
• Mentor junior developers and share best practices.

Compliance Specialist

• Develop and maintain web applications using modern technologies
• Collaborate with cross-functional teams to deliver high-quality software
• Participate in code reviews and contribute to technical architecture decisions
• Mentor junior developers and share best practices

• Manage recruitment processes from beginning to end
• Develop and implement HR strategies and initiatives
• Collaborate with department heads to understand hiring needs

• Serve as the senior IT leader for the technology ecosystem supporting product development, clinical, and regulatory functions
• Lead a large-scale enterprise portfolio driving technology strategy, execution, and operational performance
• Partner with executive leaders across R&D, Clinical Affairs, Regulatory, and Quality to align technology to business priorities
• Define and lead technology strategies, architecture roadmap, and delivery of platforms supporting PLM, clinical, and regulatory functions
• Own an IT portfolio, including prioritization, roadmap planning, phase-in/phase-out decisions
• Function as a trusted advisor, translating business priorities into scalable technology solutions
• Oversee enterprise platforms, ensuring performance and service delivery
• Drive adoption of AI and emerging technologies in regulated environments
• Manage strategic partners and vendors

VP, IT – R&D, Regulatory & Clinical Affairs

• Serve as a regulatory representative on multidisciplinary program teams for one or more investigational products
• Contribute to the development and execution of global regulatory plans aligned with program objectives and development timelines
• Support regulatory planning across the product lifecycle, from early clinical development through registration planning and lifecycle management
• Evaluate regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning
• Partner closely with cross functional development team and program leadership to support development objectives and regulatory requirements
• Support the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements
• Independently manage assigned regulatory submission activities, including preparation and coordination of INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and other regulatory documents
• Monitor and interpret global regulatory requirements, guidance documents, and policy developments relevant to assigned programs

Senior Manager/Associate Director, Regulatory Affairs

• Independently prepare IND Modules for routine submissions
• Support regulatory affairs leadership in preparation of complex submissions
• Perform thorough independent background research through all pertinent search engines
• Ensure that documents appropriately evaluate and present data and methodology
• Navigate and obtain information for projects from all available resources
• Produce timely, scientifically accurate data summaries
• Construct documents in a manner consistent with applicable regulations and guidance
• Serve as Regulatory representative in department discussions
• Interface with international affiliates on regional regulatory strategy

Regulatory Strategy Associate

• The Senior Compliance Officer – Home Lending Originations serves as the corporate compliance subject matter expert.
• Partner with other members of the second line of defense and the Home Lending line of business to identify risks.
• Develop and execute assessments, provide guidance on control and testing design and execution.
• Advise on and monitor findings and associated remediation activities.
• Participate in assigned business initiatives (i.e., new product development).
• Provide regulatory guidance and advice to Home Lending partners regarding updates and amendments to state and federal mortgage origination laws.
• Lead a strong and effective collaborative culture, responsible for partnering with various risk disciplines.
• Assist in the development and maintenance of effective compliance policies, procedures and processes.
• Address regulatory actions and other issue remediation efforts, following up and monitoring until satisfactory resolution is obtained.
• Identify, respond to and/or escalate risks as appropriate.

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