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.

• Support the design and enhancement of the Third Party Risk Management program • Ensure alignment with regulatory requirements and industry leading practices • Identify program enhancements in support of emerging risks impacting outsourced products/services • Contribute to execution and optimization of due diligence and ongoing monitoring risk assessments

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support new clinical indications and expand the HistoSonics product portfolio. This role is responsible for driving regulatory pathways that enable market access, ensuring compliance with applicable pre- and post-market requirements, and guiding regulatory strategy across new product development initiatives. As a key strategic partner to cross-functional teams, the Director helps advance targeted clinical applications and supports successful product launches across multiple anatomical areas, including but not limited to neurological, abdominal, and women’s health indications. This position is currently an individual contributor role with the opportunity to build and lead a regulatory team as the organization grows. Key Responsibilities - Working with the VP of Regulatory Affairs, craft regulatory strategies in support of HistoSonics new clinical applications goals. - Execute regulatory strategy for HistoSonics product portfolio to ensure timely commercialization of new clinical indications for targeted markets. - Collaborate with Medical and Clinical teams to define clinical data needs at various stages of market access, including feasibility, pivotal and post-market settings. - Collaborate with development teams to identify and navigate regulatory requirements and provide guidance to ensure rapid, timely clearance of new and modified products. - Review and approve, where applicable, Design History File documents, Document Change Requests to ensure compliance and identify when design changes require regulatory submissions prior to implementation. - Participate and provide regulatory guidance and support to cross-functional teams. - Serve as a Regulatory reviewer and approver of device labeling and promotional materials, including but not limited to user manuals, website, press release, brochures, company sponsored training activities, published literature and speaker presentations to ensure compliance with applicable regulations. - Manage Regulatory support staff in the completion of their duties. - Other duties as assigned or necessary to meet department and business objectives. Qualifications - Bachelor's degree, preferably in technical discipline. Regulatory Affairs Certification is preferred. - 10+ years of progressive roles in regulatory affairs in the medical device/healthcare industry. Experience within regulatory agencies may be considered in lieu of industry experience. - Experience in handling regulatory affairs for complex electro-mechanical medical devices involving software preferred. - Experience gaining regulatory market access for devices requiring prospective clinical data. - Experience with medical device regulations in the US & EU. - Proven regulatory experience with demonstrated leadership and the ability to thrive in a dynamic, evolving environment. - Strong written and verbal communication skills, with the ability to translate complex technical concepts for diverse audiences and lead high-level discussions. - Experience assessing clinical data needs and developing or refining clinical narratives for regulatory submissions. - Demonstrated ability to build collaborative relationships internally and externally and influence cross-functional stakeholders without direct authority. - Strong organizational skills with the ability to prioritize multiple deadlines, drive initiatives to completion, and translate strategy into clear product, development, or operational objectives. - Analytical, detail-oriented problem solver aligned with broader organizational goals. - Willingness to travel up to 20%. Benefits - Comprehensive benefits package for full-time employees. - Health, dental, and vision insurance. - Life, short-term and long-term disability insurance. - 401(k). - Paid time off. - More benefits.