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Kalysha Rivera
Regulatory Affairs Specialist III at Thermo Fisher Scientific
Professional Background
Kalysha Rivera is an accomplished professional in the fields of product design, regulatory compliance, and manufacturing engineering. With a strong educational foundation and extensive experience across several reputable organizations, she has proven to be a valuable asset in ensuring product safety and regulatory adherence within the industry.
Currently, Kalysha holds the position of Regulatory Affairs Specialist III at Thermo Fisher Scientific, where she utilizes her expertise to navigate the complex landscape of compliance and regulatory standards. Her role is integral to ensuring that Thermo Fisher’s diverse product lines comply with the latest regulations and safety standards, ultimately contributing to the success and reputation of the company in the life sciences sector.
Before her tenure at Thermo Fisher Scientific, Kalysha made significant contributions as a Compliance Engineer at Keurig Dr Pepper Inc. and Digital Lumens. In these positions, she was responsible for ensuring that products met safety and regulatory benchmarks, playing a crucial role in product development cycles. Her experience here honed her skills in product safety and quality assurance, further establishing her competence in regulatory affairs.
Prior to that, Kalysha worked as a Product Safety and Regulatory Compliance Engineer at Tokyo Electron U.S. Holdings, Inc. and TEL FSI, Inc., where she advanced from Tier 1 to Tier 2 positions. This progression underscores her growing expertise and responsibility in handling regulatory compliance from the onset of product design through to manufacturing.
Kalysha's career began as a Quality Engineer at EI Microcircuits, where she focused on quality assurance processes that are critical in the highly regulated electronics industry. This role laid the groundwork for her subsequent specialization in regulatory affairs, fueling her passion for safeguarding public health and safety through compliance.
Kalysha's journey also includes vital early experiences as a Manufacturing Engineering Intern at Alumacraft Boat Co. and Emerson Network Power. These internship opportunities provided her with hands-on exposure to the manufacturing processes and principles, allowing her to apply theoretical knowledge in real-world settings and make informed decisions throughout her later career.
Education and Achievements
Kalysha’s educational journey is marked by her dedication to mastering the technical aspects of product design and manufacturing. She began her studies with an Associate of Applied Science (AAS) in Product Design and Development at Northwest Technical Institute. This degree provided her with essential skills in design processes, product functionality, and market analysis, setting a robust foundation for her future endeavors.
Following her AAS, Kalysha pursued a Bachelor of Science in Manufacturing Engineering Technology at Minnesota State University, Mankato. This comprehensive program equipped her with advanced knowledge in manufacturing processes, materials science, and engineering principles, further enhancing her qualifications for a successful career.
Kalysha consistently strives for professional growth and development. Her commitment to continuous learning is evident through her progression in various roles and responsibilities. She remains actively engaged with industry standards and best practices, ensuring she remains at the forefront of innovation in the manufacturing and regulatory sectors.
Notable Achievements
As an influential figure in the realm of regulatory affairs and compliance, Kalysha Rivera has achieved numerous milestones throughout her career. Some of her most notable accomplishments include:
- Successfully leading cross-functional teams to ensure product compliance with international standards, significantly reducing the time to market for key products at Thermo Fisher Scientific.
- Developing and implementing comprehensive compliance strategies at Keurig Dr Pepper Inc., which improved the company’s oversight of product safety and regulatory adherence.
- Contributing to the design and safety evaluation of innovative products at Digital Lumens, significantly enhancing the quality assurance processes in place.
- Playing a pivotal role in regulatory submissions and certifications at Tokyo Electron U.S. Holdings, Inc., ensuring smooth approval processes for new technologies.
Kalysha’s background blends a deep understanding of product design and manufacturing with a passion for regulatory compliance. Her ability to bridge the gap between engineering and regulatory requirements enables her to advocate for both safety and innovation, driving success in every project she undertakes.
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