Medical Regulatory Compliance Manager

Company: Celanese Emulsions
Location: Irving
Posted on: January 12, 2021

Job Description:

Overview:Celanese is a Fortune 500 global chemical innovation company that engineers and manufactures chemicals used in products essential to everyday living. Headquartered in Dallas, TX, we employ over 7,700 dedicated people working between 43 facilities across 18 countries. We are committed to employee growth and creating shareholder value to ensure continued opportunities make a difference. Our company focuses on the safety of its employees, provides competitive compensation (including benefits starting day 1), and emphasizes giving back to the community. For more information about Celanese and our products please visit Responsibilities:Celanese is looking for an experienced individual to lead a team of Regulatory Compliance professionals supporting the Engineered Materials (EM) medical products team. This is a strategic leadership role and will report to the Global Product Stewardship Director. Location is Dallas, TX.In this role, you will:Partner with the business and provide regulatory leadership to the Commercial Medical team.Develop, maintain, and execute domestic and foreign/international regulatory strategies to ensure that Celanese is positioned to meet strategic corporate goals.Monitor global regulatory developments, especially in EU and USA, affecting business programs and products, communicate emerging opportunities, potential risks and mitigation strategies to stakeholders.Identify regulatory developments that Celanese needs to address to retain or grow business in key areas and drive action in partnership with Commercial and Marketing teams. Represent Celanese credibly (directly or via direct reports) in regulatory discussions with customers and serve as an important differentiator in their buying decision.Serve as the in-house subject matter expert (SME) (or find appropriate external resources) and evaluate new medical products and segments (e.g., Oral Dosage Regulatory pathway, Implantable products/polymer requirements, etc.)Design and implement training on pertinent regulatory topics for regulatory staff and key business stakeholders (e.g., Marketing, Sales and R&D) Direct the development and implementation of policies and procedures required for a robust regulatory compliance program for the medical products portfolio. Identify opportunities for continuous improvement that have a significant impact on cost, turnaround time, cycle time, etc.Play an active leadership role and represent the interests of the company in trade associations, professional organizations, and standards development organizations.Lead or participate in the cross functional Product Risk Management (PRM) process.Manage and provide leadership for a staff of regulatory professionals.Qualifications:Required Skills & Qualifications: Bachelor's degree in Chemistry, Engineering, Physical or Biological science or related field of study.Minimum of 10 years--- regulatory experience in the medical device, pharmaceutical and/or diagnostic area.Minimum 5 years--- experience managing a medical regulatory affairs team.Experience leading strategy globally and facilitating cross-functional Risk Assessments (RA).Demonstrated success preparing, filing, and completing (including internal and external negotiations) regulatory submissions (e.g. 510(k), PMA, Technical Files, 30-Day Notices, Amendments and other regulatory documentation).Strong working knowledge of FDA and EU Medical Device Directive and Medical Device regulations is required.Experience interpreting subjective and complex regulations and translating them into practical compliance strategies and programs.Experience supporting product development including multi-functional projects involving ambiguity and rapid change.Proficiency in understanding advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.Familiarity with EU and FDA cGMP requirements for components used in medical applications (Excipients, medical device components, medical packaging, diagnostics, etc)Strong interpersonal, organizational and problem-solving skills.Ability to manage and prioritize effectively to meet competing deadlines.Preferred Skills & Qualifications:Knowledge of other international medical device requirements (e.g. China, Brazil, India) highly desiredProject Management experience is preferred.RAPS Regulatory Affairs Certification (RAC) preferred.Job SummaryCity: IrvingState/Province: Texas

Keywords: Celanese Emulsions, Irving , Medical Regulatory Compliance Manager, Executive , Irving, Texas