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Director, Regulatory Quality | PMO
Director, Regulatory Quality | PMO-November 2024
Austin
Nov 28, 2024
ABOUT ENOVIS
An innovation-driven medical technology company dedicated to developing clinically differentiated solutions that generate better patient outcomes
5,001 - 10,000 employees
Healthtech
VIEW COMPANY PROFILE >>
About Director, Regulatory Quality | PMO

  Job Description:

  At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

  Because that's how we change the lives of patients for the better. And that's how we create better together.

  As a key member of the Regulatory Affairs | Quality Assurance (RA|QA) team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

  Job Title:

  Director, Regulatory Quality | PMO

  Reports To:

  VP, Global Quality & Regulatory Affairs

  Location:

  Austin, Texas

  Business Unit:

  Regulatory Affairs | Quality Assurance (RA|QA)

  Job Title/High Level Position Summary:

  The Director of RA/QA Project Management Office (PMO) will develop and execute project plans for implementing US and EU standards, performing due diligence, and managing integration projects.

  Key Responsibilities:

  Project Planning and ExecutionDevelop and apply assessment tools for scoping projects effectivelyDevelop realistic plans and efficient processes for managing assigned projectsDevelop tracking mechanisms and communicate progress to relevant stakeholdersIdentify and communicate areas of risk and develop remediation plansManage timeline effectively to deliver on commitmentsConsult with Business Leaders and the DJO Executive team in the identification of project scope and expectations, and create alignment of the leadership teams to the requirements of the projectCommunication and presentation of project status, performance to timeline and budget, and risk / opportunities within the project scopeRecommend changes to policies, procedures, and work instructions for PMO activities and as a result of project outputsWork with internal and external teams for effective change management to include Clinical, Manufacturing, Marketing, Quality, Regulatory, Research & Development, Supply Chain, and external suppliersInvolvement in acquisition / divestiture diligence, and the communication of the summary of those activities to the executive teamManagement and support of integration and divestiture activities, and the direct interaction with personnel responsible for the execution of those activitiesDevelopment of processes, procedures, tools needed to ensure effective and efficient actions related to mergers, acquisitions, divestitures, and integrationsAdditional responsibilities as required

  Minimum Basic Qualifications:

  EDUCATION/CERTIFICATION:

  Bachelor's Degree in a scientific or health-related field desired or equivalent work experiencestandards and requirementsPrevious management experience is preferred

  REQUIRED KNOWLEDGE:

  Excellent written and verbal communication skillsDemonstrated ability to work with people in an effective and positive mannerFood and Drug Administration (FDA) regulations and guidelinesISO 13485 and MDD

  EXPERIENCE REQUIRED:

  10 years relevant experience in Medical Device or closely related industry5+ years in a Regulatory or Quality Compliance role, or equivalent knowledge of RA/QA Experience with Agile PLM, Oracle ERP, and/or BarTender software preferredOracle experience as an ERP preferred (Inventory, MRP, ASCP)Proficient in Microsoft Office Suite (Excel, Word, and Power Point)

  "Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

  Watch this short video and discover what creating better together means to us at Enovis:

  Our Enovis Purpose, Values and Behaviors on Vimeo

  ABOUT ENOVIS

  Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.

  EQUAL EMPLOYMENT OPPORTUNITY:

  Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

  ABOUT DJO GLOBAL

  DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. Our products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Our products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of our medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, Exos™, Dr. Comfort®, DonJoy Performance® and DJO® Surgical.

  For additional information on the Company, please visit www.DJOglobal.com.

  DJO is a growing subsidiary of diversified technology leader Colfax Corporation

  EOE AA M/F/VET/Disability

  All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

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