- Work closely with Operations, R&D teams, Sustainability and Commercial teams to ensure all materials, products and byproducts manufactured/imported or distributed by Kraton are in compliance with all necessary regulatory requirements regarding manufacture, handling, use and sale in the regions in which we manufacture and do business.
- Investigate and resolve complex customer requests in cooperation with commercial and legal (as needed).
- Maintain a thorough understanding of the regulations in regions assigned.
- Maintain a thorough understanding of the needs and strategy of the supported Business Units and devise, communicate and execute plans to meet the identified tactical and strategic goals for commercialization.
- Perform regulatory impact analysis on changing regulations; communicate impact to all key stakeholders and lead development of necessary actions.
- Plan and execute periodic audits for GMP or ISO purposes.
- Act as focal point for MOC review and approval for Product Regulatory discipline as assigned.
- Lead design of new processes and improve existing processes.
- Act as subject matter expert in at least two major regulatory areas, primarily sensitive applications such as food contact, medical, hygiene and cosmetics.
- Conduct periodic internal training related to product regulatory issues and requirements.
- Drive technical direction of industry associations in which they participate.
- Coordinate, monitor and assess results of needed testing for new and existing products.
- Plan and execute complex regional and at times global multi-functional projects and present project summaries to management levels.
- 8+ years of in Product Regulatory or Product Stewardship
- Proficient in knowledge of polymers and plastics, product lines, manufacturing processes, uses, etc.
- Proficient in international chemical control, REACH, hazard communication and other critical regulations (i.e. food contact, medical device, cosmetic, etc.).
- Ability to conduct complex analysis of products for regional, and at times global, compliance and create communication strategy to promote compliance.
- Ability to effectively communicate within the organization, with customers, industry organizations, consultants, laboratories and government agencies.
- Project Management and Lean skills an asset.
- Internal auditing certification and experience an asset.
- Proficient in English required, other languages to support Europe and Asia an asset.
- Bachelor's degree in Chemistry or related field required.
- A supportive work environment that values teamwork and collaboration.
- A chance to make a real positive difference in the industry.
- Competitive salary and comprehensive benefits package.
- Opportunity to work with a talented and diverse team of professionals in the field.
- Continuous learning and development opportunities to enhance your skills.
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Senior Product Regulatory Specialist - Almere, Nederland - Kraton
Beschrijving
Make a +Difference at Kraton
At Kraton, we make a Positive Difference, and we are looking for individuals who are also looking to make a difference in their jobs, for our customers and to the world. We are looking to hire a key member of our Product Safety and Regulatory Affairs team at our Almere location.
Are you a seasoned professional in regulatory affairs with a passion for polymers? An exceptional opportunity awaits you to elevate your career as a Senior Product Regulatory Specialist in our dynamic team The Senior Product Regulatory Specialist is responsible for working with internal and external stakeholders to ensure Polymer product portfolio (raw materials, products, byproducts manufactured, imported or distributed) is in compliance with regulatory requirements in various jurisdictions with a focus on EU, other European countries and potentially China.
Key Responsibilities
Required Skills
Education, Certifications & Licenses
What We Offer
The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
Kraton's internal talent acquisition team manages our recruiting efforts and from time to time works with pre-selected/pre-approved external staffing agencies. We do NOT accept unsolicited resumes or candidate referrals from recruiters and/or agencies who are not pre-selected/pre-approved.
Kraton is proud to be an Equal Opportunity Employer.
