Regulatory Affairs Specialist Ii
Current
Sep 2024 - Present
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Divya Lekkala Email & Phone Number
Regulatory Affairs Specialist - Spectrum Plastics Group | Regulatory Affairs - Northeastern University | Ex- Co-Op Biogen | Ex- Celegence Employee | EU MDR | Medical Writer | M.Pharmacy (Pharmaceutical Technology)
at
Spectrum Plastics Group, A DuPont Business
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✓ Verified Jun 2026
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Current company
Role
Regulatory Affairs Specialist - Spectrum Plastics Group | Regulatory Affairs - Northeastern University | Ex- Co-Op Biogen | Ex- Celegence Employee | EU MDR | Medical Writer | M.Pharmacy (Pharmaceutical Technology)
Location
Tucson, Arizona, United States
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Who is Divya Lekkala? Overview
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Quick answer
Divya Lekkala is listed as Regulatory Affairs Specialist - Spectrum Plastics Group | Regulatory Affairs - Northeastern University | Ex- Co-Op Biogen | Ex- Celegence Employee | EU MDR | Medical Writer | M.Pharmacy (Pharmaceutical Technology) at Spectrum Plastics Group, A DuPont Business, a company with 238 employees, based in Tucson, Arizona, United States. AeroLeads shows a matched LinkedIn profile for Divya Lekkala.
Divya Lekkala previously worked as Regulatory Affairs Specialist II at Spectrum Plastics Group, A Dupont Business and Regulatory Affairs Intern - XN Project at Crown Medical Research And Pharmaceutical Sciences College Of Canada. Divya Lekkala holds Master Of Science - Ms, Regulatory Affairs, 3.9 from Northeastern University.
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Spectrum Plastics Group, A DuPont Business
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Profile bio
About Divya Lekkala
Passionate Regulatory Affairs professional with a robust academic foundation and three years of hands-on experience in the dynamic medical device and pharmaceutical industries. Skilled in crafting effective regulatory strategies, adeptly managing project timelines, and meticulously preparing submission documents for various regulatory pathways, including 510(k)s, IDEs, PMAs, PMSRs, and CERs, in alignment with FDA and EU MDR guidelines.Demonstrated proficiency in meticulously reviewing and approving product labeling and marketing claims to ensure strict regulatory compliance. Extensive expertise in facilitating CE marking activities, encompassing the meticulous preparation and maintenance of product technical files and comprehensive clinical evaluations.Furthermore, I possess in-depth knowledge of cGMP, quality assurance principles, and change controls within the pharmaceutical domain. Proficient in document management and adept at developing and implementing Standard Operating Procedures (SOPs) in accordance with Good Documentation Practices (GDP) standards, ensuring adherence to regulatory requirements.Recognized for achieving milestones, including implementing automated reference linking capabilities at Biogen and authoring systematic literature review reports and clinical evaluation documents at Celegence Systems. Received accolades such as the Lean Six-Sigma Yellow belt certification and Bravo Award for outstanding performance.Eager to leverage my multifaceted skill set and industry knowledge to drive regulatory excellence and contribute to the success of innovative projects within the medical device and pharmaceutical landscape.
Current workplace
Divya Lekkala's current company
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Spectrum Plastics Group, A Dupont Business
6 roles
Divya Lekkala work experience
A career timeline built from the work history available for this profile.
Regulatory Affairs Intern - Xn Project
Internship project in collaboration with Northeastern University Experiential Network (XN) and Crown College of Canada.Internship Supervisor: Professor Peivand Pirouzi, Ph.D.Preparation of submission documents to meet Health Canada's validation criteria and CTD submissions, ensuring full compliance with the Canadian and International regulatory.
Jan 2024 - Jul 2024
Co-Op, Material Review Operations Partners
Developed and implemented an automated reference linking capability and library within Veeva Vault, enhancing efficiency in managing advertising, labeling, promotional, scientific statements, and marketing claims.Collaborated with cross-functional teams to gather data and assess complaint communications for regulatory compliance, reportability, and.
Jul 2023 - Dec 2023
Medical Writer Ii
- Author for systematic literature review reports, clinical evaluation plan (CEP) and clinical evaluation reports (CER) for devices in compliance with MEDDEV 2.7/1 Rev.4 and EU MDR for CE making and approval. Prepared.
- Review systematic… Show more
- Review systematic literature searches on PubMed, Cochrane, Prospero and Embase database. interpretation of clinical trial searches on EU Clinical Trials, US Clinical Trials, Cochrane Trials and WHO ICTRP websites.
- Analysis of adverse event reports, recalls, field safety corrective actions and field safety notices on US FDA MAUDE, US FDA TPLC, MHRA, BfArM and Swissmedic databases. Prepared and facilitated 510(k), PMA, IDE.
- Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. Show less
Jun 2021 - Aug 2022
Associate Analyst
- Authored clinical evaluation protocols, CEPs, CERs by screening literature, clinical documentation, risk management and technical files and ensured data accuracy, consistency and compliance with EU IVDR.Reviewed and.
- Implemented change controls and raised change orders… Show more Authored clinical evaluation protocols, CEPs, CERs by screening literature, clinical documentation, risk management and technical files and ensured data.
- Implemented change controls and raised change orders within the Quality Management System (QMS), ensuring proper documentation and adherence to regulatory standards.
- Spearheaded review activities for artworks, promotional material, labelling and advertising material ensuring accuracy and adherence to regulatory compliance.
- Creation of change order and change awareness notification as per the variations raised to manufacturer products in E.U region as part of Global Labelling activities.
- Update artworks to all the markets of European Union for all the manufacturer products according to EMA variations using Harmony Tool.
Feb 2020 - May 2021
Regulatory Affairs Intern
Pfizer Healthcare India
Conducted systematic literature searches and screening using PubMed, Cochrane, Embase and Google Scholar. Analyzed and collated clinical trial data from EU Clinical Trials, US Clinical Trials, & WHO ICTRP databases for medical devices.Ensured consistency, periodic updates, implementation of change order and change awareness notifications for artworks and.
Jun 2018 - Aug 2019
Team & coworkers
Colleagues at Spectrum Plastics Group, A DuPont Business
Other employees you can reach at spectrumplasticsgroup.com. View company contacts for 238 employees →
PP
Priya Puri
Colleague at Spectrum Plastics Group, A Dupont BusinessPark City, Utah, United States, United States
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LJ
Leticia Juárez
Colleague at Spectrum Plastics Group, A Dupont BusinessMexico, Mexico
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DD
Daniel Dennington
Colleague at Spectrum Plastics Group, A Dupont BusinessSpringfield, Missouri, United States, United States
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NF
Nikki Fuller
Colleague at Spectrum Plastics Group, A Dupont BusinessTullamore, County Offaly, Ireland, Ireland
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SO
Shala Overstreet
Colleague at Spectrum Plastics Group, A Dupont BusinessMission Viejo, California, United States, United States
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JT
Julie Traxler
Colleague at Spectrum Plastics Group, A Dupont BusinessChaska, Minnesota, United States, United States
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MW
Michele Warzetha
Colleague at Spectrum Plastics Group, A Dupont BusinessMinneapolis, Minnesota, United States, United States
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NK
Nancy Kreb Phillips
Colleague at Spectrum Plastics Group, A Dupont BusinessOceanport, New Jersey, United States, United States
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RR
Roberto Rodriguez
Colleague at Spectrum Plastics Group, A Dupont BusinessMexicali, Baja California, Mexico, Mexico
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MI
Mariel Inzunza
Colleague at Spectrum Plastics Group, A Dupont BusinessMexicali, Baja California, Mexico, Mexico
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Priya Puri
Colleague at Spectrum Plastics Group, A Dupont BusinessPark City, Utah, United States, United States
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LJ
Leticia Juárez
Colleague at Spectrum Plastics Group, A Dupont BusinessMexico, Mexico
View →
DD
Daniel Dennington
Colleague at Spectrum Plastics Group, A Dupont BusinessSpringfield, Missouri, United States, United States
View →
NF
Nikki Fuller
Colleague at Spectrum Plastics Group, A Dupont BusinessTullamore, County Offaly, Ireland, Ireland
View →
SO
Shala Overstreet
Colleague at Spectrum Plastics Group, A Dupont BusinessMission Viejo, California, United States, United States
View →
JT
Julie Traxler
Colleague at Spectrum Plastics Group, A Dupont BusinessChaska, Minnesota, United States, United States
View →
MW
Michele Warzetha
Colleague at Spectrum Plastics Group, A Dupont BusinessMinneapolis, Minnesota, United States, United States
View →
NK
Nancy Kreb Phillips
Colleague at Spectrum Plastics Group, A Dupont BusinessOceanport, New Jersey, United States, United States
View →
RR
Roberto Rodriguez
Colleague at Spectrum Plastics Group, A Dupont BusinessMexicali, Baja California, Mexico, Mexico
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MI
Mariel Inzunza
Colleague at Spectrum Plastics Group, A Dupont BusinessMexicali, Baja California, Mexico, Mexico
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4 education records
Divya Lekkala education
Master Of Science - Ms, Regulatory Affairs, 3.9
Master'S In Pharmacy (M. Pharm), Pharmaceutical Sciences, 8.15 Cgpa
Bachelor Of Pharmacy - Bpharm, Pharmacy, 83.15 Per Cent
School, 9.6 Cgpa
FAQ
Frequently asked questions about Divya Lekkala
Quick answers generated from the profile data available on this page.
What company does Divya Lekkala work for?
Divya Lekkala works for Spectrum Plastics Group, A DuPont Business.
What is Divya Lekkala's role at Spectrum Plastics Group, A DuPont Business?
Divya Lekkala is listed as Regulatory Affairs Specialist - Spectrum Plastics Group | Regulatory Affairs - Northeastern University | Ex- Co-Op Biogen | Ex- Celegence Employee | EU MDR | Medical Writer | M.Pharmacy (Pharmaceutical Technology) at Spectrum Plastics Group, A DuPont Business.
Where is Divya Lekkala based?
Divya Lekkala is based in Tucson, Arizona, United States while working with Spectrum Plastics Group, A DuPont Business.
What companies has Divya Lekkala worked for?
Divya Lekkala has worked for Spectrum Plastics Group, A Dupont Business, Crown Medical Research And Pharmaceutical Sciences College Of Canada, Biogen, Celegence, and Tech Mahindra.
Who are Divya Lekkala's colleagues at Spectrum Plastics Group, A DuPont Business?
Divya Lekkala's colleagues at Spectrum Plastics Group, A DuPont Business include Priya Puri, Leticia Juárez, Daniel Dennington, Nikki Fuller, and Shala Overstreet.
How can I contact Divya Lekkala?
You can use AeroLeads to view verified contact signals for Divya Lekkala at Spectrum Plastics Group, A DuPont Business, including work email, phone, and LinkedIn data when available.
What schools did Divya Lekkala attend?
Divya Lekkala holds Master Of Science - Ms, Regulatory Affairs, 3.9 from Northeastern University.
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