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Product Stewardship & Regulatory Affairs

Job Requisition ID:  38251

Founded in 1920, Eastman is a global specialty materials company that produces a broad range of products found in items people use every day. With the purpose of enhancing the quality of life in a material way, Eastman works with customers to deliver innovative products and solutions while maintaining a commitment to safety and sustainability. The company's innovation-driven growth model takes advantage of world-class technology platforms, deep customer engagement, and differentiated application development to grow its leading positions in attractive end-markets such as transportation, building and construction, and consumables. As a globally inclusive and diverse company, Eastman employs approximately 14,500 people around the world and serves customers in more than 100 countries. The company had 2020 revenues of approximately $8.5 billion and is headquartered in Kingsport, Tennessee, USA. For more information, visit www.eastman.com.

Responsibilities

The position of Regulatory Compliance and Clearance Expert will be based out of our Kingsport, TN headquarters (working remotely will be considered).  
 
Scope:
The candidate will work on assignments to ensure Eastman products receive and maintain appropriate clearances for use in the highly regulated application of medical devices under the U.S. Food, Drug and Cosmetic Act and similar laws around the world.  The position reports into the Global Product Stewardship and Regulatory Affairs (PSRA) organization.  The successful candidate will work closely with Product Stewardship and Subject Matter Experts in PSRA.  Outside of PSRA, the candidate should expect to regularly engage key internal stakeholders within Eastman’s business units, Technology, Legal and Analytical Services.  The scope of the role includes the support of existing products, and the development and commercialization of new products in the application area.  Finally, the candidate’s engagement with external stakeholders such as customers, regulatory authorities and industry associations will be of utmost importance in this position.
 
Tasks and responsibilities:
 
·    Acquire in-depth product knowledge of our current and developing medical device application portfolio, in order to answer compliance related questions from internal stakeholders, partners, external parties and engaging new and existing customers in critical discussions.  
·    Create testing proposals to support regulatory clearance for new and existing products in medical device applications.
·    Interpret analytical results, reports and other technical information in order to support existing compliance of our products or to prepare for new submissions to the US FDA and similar regulatory agencies around the world.
·    When needed, support and defend new clearance dossiers before regulatory authorities.
·    Provide appropriate information to promote the safe use of our products throughout their entire life-cycle to: 
·    Internal Stakeholders - including product stewardship experts, manufacturing, technology, product management and sales and marketing personnel.
·    External Stakeholders – including customers, distributors and industry partners.
·    Evaluate and ensure continued compliance with existing regulatory clearances as technology, raw materials, use patterns and governmental requirements change.
·    Work closely with members of the Eastman Law Department and/or contracted regulatory consulting companies and external service providers.
·    Develop/maintain a sound awareness of global trends in medical device related regulations.
·    Participate in advocacy and regulatory compliance initiatives.  Represent Eastman in trade associations and organizations.
·    As part of a team of subject matter experts, and in addition to medical devices, this role will also cover other US FDA-related product lines (e.g. drugs, cosmetic ingredients, etc.), as needed.
 

Qualifications

Strong candidates for this position should have many of the following skills or be willing to be trained in these areas:
 

·    Education – B.S. or higher degree in Polymer Science, Chemistry, Engineering, or related-scientific field.
·    Experience – 2 to 5 years of experience in FDA medical device-related product stewardship/regulatory compliance expertise.  Experience, in drug-related applications (e.g. Drug Master Files) is a plus.
·    Comprehension and demonstrated application of procedures/processes used for the approval of medical device applications in the US, EU and/or around the world.
·    Hands-on product stewardship/compliance experience in clearances for medical device applications.
·    Ability to work independently and on multiple projects simultaneously.
·    Ability to work effectively in a team and matrix organization together with other regulatory and scientific subject experts, and with business organizations.
·    Be skilled in translating complex scientific topics into comprehensible key messages for different audiences.
·    Ability to engage effectively with authorities, customers, industry groups and other stakeholders.
·    Have strong communication skills, both written and orally.
·    Positive and supportive attitude is a must.
·    Proactive, technically competent, assertive, and ability to successfully perform in high-pressure, globally, and culturally diverse environments.
·    Ability to make decisions with incomplete data.
·    Travel occasionally, primarily within North America; but, other geographies are a possibility.
·    Speak and write fluent English is mandatory for the position.
 

Eastman Chemical Company is an equal opportunity employer.  All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other characteristics protected by law.

Eastman is committed to creating a powerfully diverse workforce and a broadly inclusive workplace, where everyone can contribute to their fullest potential each day.


Nearest Major Market: Asheville
Nearest Secondary Market: Knoxville

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