Product Stewardship - Regulatory Expert, Medical Applications

Job not on LinkedIn

June 19

Apply Now

Receive Emails with Similar Jobs

The Chemours Company

WebsiteLinkedInAll Job Openings

Chemicals • Automotive • Energy

The Chemours Company is a global leader in chemical manufacturing, focused on leveraging chemistry to create reliable and sustainable solutions. The company offers a diverse range of brands and products, including Opteon™, Ti-Pure™, Nafion™, Viton™, Krytox™, Freon™, and Teflon™, catering to industries like automotive, advanced electronics, energy, and medical applications. Chemours is dedicated to driving innovation within the electric vehicle sector and enabling modern technologies with advanced materials. Furthermore, the company prioritizes sustainability with a commitment to responsible manufacturing and creating a positive environmental impact. Chemours’ efforts are supported by its emphasis on innovation, strategic growth, and community engagement.

5001 - 10000 employees

Founded 2015

⚡ Energy

📋 Description

• Coordinate medical application reviews according to internal standards and organize appropriate documentation • Identify and implement improvements to internal processes with a focus on medical application reviews. • Support global product stewardship, regulatory and sustainability teams including product development, business initiatives and market assessments ensuring regulatory and voluntary standard integration and compliance in conjunction with corporate global sustainability metrics and goals. • Monitor and communicate regulatory changes that impact Chemours products to the relevant stakeholders. • Monitor and analyze regional regulatory and market trends, and industry/stakeholder group positions and sustainability initiatives to bring business perspective. • Interface with service providers, outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. • Coordinate and review customer agreements/contracts with legal and business functions. • May be involved in business strategy decisions by working/leading a cross functional team to present and support medical application overviews. • Assist the business with responses to compliance-specific questions (from customers, agencies, and other stakeholders). • Creating and delivering training to partners in the business unit to increase their regulatory awareness.

🎯 Requirements

• Bachelor's degree in Chemistry, Biochemistry, Chemical or Environmental Engineering, Biological Science, Toxicology or comparable technical field • 5+ years of medical device regulatory compliance experience with respect to raw material components and/or 5+ years’ experience assessing risk associated with materials supplied to medical device customers • Familiarity with US medical device regulations and standards that impact a customers’ material selection • Influence leadership / networking skills with internal and external stakeholders (customers, suppliers, industry trade associations, regulatory and governmental authorities, etc.) to address regulatory and market-access requirements • Demonstrates project management, communications, and teamwork skills along with problem solving capability, attention to detail and accuracy

🏖️ Benefits

• Competitive Compensation • Comprehensive Benefits Packages • 401(k) Match • Employee Stock Purchase Program • Tuition Reimbursement • Commuter Benefits • Learning and Development Opportunities • Strong Inclusion and Diversity Initiatives • Company-paid Volunteer Day