Medical Regulatory Compliance Manager
Company: Celanese Emulsions
Location: Irving
Posted on: January 12, 2021
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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
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