• Define and execute regulatory strategies for AI/ML-enabled medical devices across global markets (e.g., U.S., EU, Canada, APAC). • Prepare, review, and complete regulatory submissions to global regulatory authorities (e.g., FDA 510(k), De Novo, CE Mark, Health Canada). • Serve as a primary regulatory representative on assigned projects, supporting interactions with regulatory authorities during submission preparation and review. • Independently coordinate cross-functional teams for timely regulatory documentation.

Overview LEARN Behavioral is a national organization made up of dedicated and caring individuals with the sole purpose of nurturing children with autism and special needs to lead resilient and fulfilling lives. We specialize in contemporary, evidence based applied behavior analysis to deliver personalized treatment plans, backed by 20 years of clinical insights. We are proud to be a part of each family’s journey and share in the experience of finding success for every child, and family, in our care. If you share a similar passion for nurturing and empowering the success of others, along with the opportunity to have an impact on the lives of others, we are eager to connect with you! The Operational & Clinical Compliance Coordinator is responsible for supporting the organization's adherence to regulations, policies, and procedures. Responsibilities include assisting with data management, monitoring data integrity, preparing reports, supporting audits, and providing administrative support. - Compensation starting at $19 per hour. - This is a full-time remote opportunity offering comprehensive benefits, PTO and paid holidays. - Candidates must be available to work a Monday–Friday schedule and commit to an 8.5 hour shift scheduled between 9:00 a.m. and 7:00 p.m. PST. - Candidates who are located in Pacific Time Zone (PST) are preferred. Responsibilities - Assist with preparing and verifying data for internal and external audits, ensuring accuracy and completeness. - Monitor data integrity within client and staff databases, reporting any potential discrepancies. - Compile reports and documents according to established guidelines. - Support audits and investigations, including scheduling, documentation, and communication. - Assist with communicating and upholding policies, procedures, and expectations to staff. - Responsible for the maintenance and distribution of client records in accordance with HIPAA regulations. - Facilitated the timely and accurate processing of incoming requests and information for various projects, workflows and initiatives. - Resolve daily and routine nature issues as well as exercise appropriate judgment for escalation. Qualifications - Bachelor’s Degree or equivalent preferred - Writing: Communicating effectively in writing as appropriate for the needs of the audience. - Speaking: Speaking to others to convey information effectively. - Service Orientation: Actively looking for ways to help people. - Critical Thinking: Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems. - Problem Sensitivity: The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing that there is a problem. - Selective Attention: The ability to concentrate on a task over a period of time without being distracted. - Adaptability: Open to change (positive or negative) and to considerable variety in the workplace - Attention to Detail: Job requires being careful about detail and thorough in completing work tasks. - Curiosity: Continuously expands knowledge and actively shares with colleagues. - Cooperation: Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude. - Dependability: Job requires being reliable, responsible, and dependable, and fulfilling obligations. - Analytical Thinking: Job requires analyzing information and using logic to address work-related issues and problems. LEARN Behavioral offers competitive compensation and a comprehensive benefits plan, including 401(k), personal time off, paid holidays, and tuition reimbursement. LEARN Behavioral is an Equal Opportunity Employer. Candidates must be presently eligible to work in the United States.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Work With Heart, Lead with Impact At Parexel, With Heart is more than a core value—it’s how we approach every project, partnership, and patient impact. We bring deep scientific expertise together with empathy, integrity, and genuine human connection. Our consultants don’t just guide clients through compliance challenges; they become trusted partners helping sterile drug manufacturers deliver safe, effective therapies to people worldwide. If you’re driven by quality, purpose, and the belief that your work should truly matter, this is a unique opportunity to make a global impact across multiple organizations—with heart. Why This Role Is Exceptional This isn’t a traditional industry role. It’s an opportunity to: - Amplify your influence by supporting multiple manufacturing sites and teams. - Accelerate your career through diverse, high‑visibility consulting engagements. - Apply your microbiology and aseptic expertise where it matters most—on the front lines of sterile drug product safety. - See more, learn more, and contribute more than in any single-company role. - Travel globally and gain exposure to varied technologies, cultures, and regulatory expectations. - Join a team that values people, not just deliverables, and genuinely supports your growth. If you thrive in fast-paced environments, enjoy problem‑solving, and want to directly influence product quality and patient safety, you’ll love consulting at Parexel. Position Overview The Senior / Principal Regulatory Compliance Consultant serves as a high-level subject matter expert in QC Microbiology and aseptic sterile drug product manufacturing. You will lead complex client engagements, provide hands-on technical and regulatory support, and drive sustainable quality and contamination control improvements. Candidates must bring 10+ years of progressive QC Microbiology supervisory or management experience in a sterile drug product environment. Prior consulting experience is a plus—not a requirement. We are excellent at transforming seasoned industry leaders into outstanding consultants. This role requires up to 70% domestic and international travel to support client sites. Key Responsibilities You will have the opportunity to: Serve as a trusted expert in: - QC Microbiology operations and laboratory leadership - Aseptic processing and sterile drug manufacturing - Contamination Control Strategies (CCS) - Environmental Monitoring (EM) programs - Microbial identification, trending, investigations, and CAPA oversight - Water systems, cleaning/disinfection, and sterility assurance Lead high-impact projects, including: - Designing or optimizing EM, APS, AOQ, and CCS programs - Supporting facility expansions, lab startups, and method qualifications - Conducting regulatory readiness assessments and mock inspections - Authoring and reviewing SOPs, risk assessments (HACCP, FMEA), validation protocols, and technical documentation - Leading investigations using root cause analysis principles Partner with client leadership to: - Strengthen quality systems aligned with FDA, EMA, ICH, USP, and global standards - Coach microbiology and manufacturing teams on aseptic best practices - Drive compliance improvements that enhance operational reliability and inspection outcomes - Build sustainable, risk-based programs that reduce deviations and contamination events You will be the person clients turn to when they need expert guidance, clear solutions, and leadership under pressure. Required Qualifications - 10+ years QC Microbiology experience, including supervisory or managerial responsibility - Deep experience supporting aseptic manufacturing of sterile drug products - Expertise in EM, CCS, APS, water systems, sterility assurance, and microbiology lab operations - Strong working knowledge of global regulations (FDA 21 CFR 210/211, EMA Annex 1, ICH, USP) - Proven ability to lead investigations, CAPAs, risk assessments, and data trending - Excellent communication skills with the ability to influence and educate teams - Ability to travel up to 70% domestically and internationally Preferred Qualifications - Prior consulting experience - Experience with facility startup, remediation, or major operational readiness efforts - ASQ CQA or similar certification - Experience preparing for and supporting FDA/EMA regulatory inspections - Strong experience authoring technical or regulatory documentation What We Offer - A meaningful mission—improving patient safety across global manufacturing sites - High-impact work with major biopharma and sterile drug product companies - A culture of support, collaboration, and empathy—true to our “With Heart” value - Consulting development and mentorship, including structured support for those new to consulting - Flexibility—remote work when not on client site, plus variety in daily responsibilities Ready to Make a Global Impact? If you’re looking for a role where your microbiology expertise, leadership skills, and dedication to patient safety can truly change lives—and you want to do it with heart—we’d love to review your application. Apply today and bring your expertise to clients around the world—helping them make the sterile products patients rely on safer, one batch at a time. #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Provides information on the intent, applicability, and survey of standards in response to inquiries from internal and external customers within specified turnaround times to provide excellent accreditation/certification support. Provides support in the accreditation review process, as well as participates as a consultant in the development and revision of standards and survey process. Serves as faculty for surveyors and other education programs and represents Joint Commission as liaison to various professional organizations. Serves as a resource to the Life Safety Code Specialists and provides additional support to accredited organizations and consultants. Is an active member of the Healthcare Environment: Technical Advisory Council (HE: TAC). Responsibilities - Provides guidance on and expert interpretation of Joint Commission standards and Medicare requirements, professional standards of practice, and law and regulation to internal and external organizations and stakeholders. - Supports the entire accreditation/certification process through the development, review and analysis of survey reports and outcomes. - Works closely with OQPS to provide support to the complaint analysis process. - Provides leadership and guidance to the Accreditation and Certification Operations (ACO) service teams in all aspects of the accreditation process. - Serves as a role model in the support of and implementation of enterprise, division and departmental mission and initiatives. - Provides direction and guidance in the consistency of standards interpretation through inquiry and FAQ management processes. - Effectively communicates with internal and external customers in a respectful, constructive and collegial style. - Embraces The Joint Commission culture of safety and serves as a role model in incorporating the SIG Department Guidelines into daily work and interactions. - Serves as a resource for Media Relations in the development of responses to inquiries from external media representatives. - Serves as Authority Having Jurisdiction (AHJ) conducting Life Safety Code building analysis. - Serves as a resource to accredited organizations and consultants specific to the National Fire Protection Association (NFPA) body of codes. - Assists various advocacy groups and represents the Joint Commission to other agencies providing standards knowledge and expertise. Qualifications - Healthcare Facilities Management experience with three to five years of progressive, leadership or supervisory experience. - Minimum bachelor’s degree (Master’s Degree or equivalent preferred) with recognized certification (i.e. CHFM, CFPS, CHSP). - Demonstrated customer service skills, including interpersonal skills related to effectively interacting with internal and external customers. - Demonstrated presentation and analytical skills. - Demonstrated ability to function well in a fast-paced, highly stressed and visible environment. - Strong computer skills preferred, including familiarity with databases, graphics, and word processing. Requirements - Must be able to lift 35 pounds. - Must be able to climb stairs and ladders. - Must be able to travel up to 25% of work time on short notice. Benefits We offer a comprehensive benefit package. For a complete overview of our benefits package, please visit our Joint Commission Career Page. Company Description This job description is intended to describe the general nature and level of work performed by an employee assigned to this position. The description is not an exhaustive list of all duties, responsibilities, knowledge, skills, and abilities, and working conditions associated with this position. All requirements are subject to possible modification and reasonably accommodate individuals with disabilities.