Hello! My name is Summer, and I'm passionate about making the world a better place through my work in regulatory affairs. I believe in the power of dedication, continuous learning, and a positive attitude to drive meaningful change.Experienced Regulatory Affairs Specialist with a strong background in regulatory affairs for medical devices, including MDR experience and FDA submissions. Proven expertise in interpreting complex regulations and ensuring compliance to bring safe and effective products to market. Skilled in understanding and applying EMA guidelines and ICH standards to streamline regulatory processes. Known for exceptional attention to detail, strong analytical skills, and effective risk management strategies. Adept at managing submission timelines and coordinating with cross-functional teams. Excellent communication skills, both verbal and written, to articulate regulatory information to diverse audiences. Committed to continuous learning and staying updated with evolving regulatory landscapes to maintain compliance and drive business success.Outside of work, I am an avid digital artist, painting comics that capture the imagination and bring stories to life. I love to exercise with my dog, enjoying the fresh air and staying active. Currently, I am also working towards a degree in Health Sciences, further deepening my understanding of the field I am so passionate about.If you have a project I can help with, please reach out via email at summerleighlong@gmail.com.
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Regulatory Affairs SpecialistOrthofixAnchorage, Ak, Us -
Regulatory Affairs AssociateBalt Usa Jul 2021 - Jul 2024Irvine, California, United States- Prepared, submitted, and maintained high-risk medical device licenses and listings across NA, APAC, EMEA, and LATAM regions.- Monitored and analyzed global legislation to assess impacts and recommended compliance actions.- Collaborated with Authorized Representatives to meet deadlines and respond to immediate legislative impacts.- Authored and maintained work instructions and technical documents.- Supported the Regulatory Affairs department during audits.
Summer Long Education Details
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Liberal Arts And Sciences, General Studies And Humanities
Frequently Asked Questions about Summer Long
What company does Summer Long work for?
Summer Long works for Orthofix
What is Summer Long's role at the current company?
Summer Long's current role is Regulatory Affairs Specialist.
What schools did Summer Long attend?
Summer Long attended Saddleback College.
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2advanceillinois.org, uchicago.edu
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Summer Long
Scottsdale, Az1thefederalsavingsbank.com -
Summer Long
Houston, Tx
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