Evita Asumugha work email
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Evita Asumugha personal email
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A clinical research scientific writer with medical and regulatory CER expertise in MEDDEV 2.7/1 rev4 documentation, EU MDR and FDA compliance. Provided strategic support in regulatory affairs, post-market product surveillance, and quality assurance in CE marking of EU Class I, IIa, IIb or III medical devices by writing Clinical Evaluation Reports (CERs) providing clinical evidence of the device's state of the art for medical treatment and its safety and performance. Experience in development of clinical trials (Ph. I – IV) documents and corresponding submissions and preparation of clinical study reports or other regulatory documents supporting ongoing clinical development programs. Narrative/systematic literature reviews: Cochrane, PubMed, Embase, Medline Ovid, DistillerSR (e.g. PRISMA), Google ScholarExcellent technical skills: peer-reviewed scientific publications, scientific presentations, and university-level teaching
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Clinical Safety ManagerFractyl Health Aug 2024 - PresentLexington, Ma, Us -
Senior Medical WriterSafeheal Jan 2024 - Present -
Senior Medical WriterMedpoint, Llc Jul 2019 - PresentGreenville, South Carolina, Us -
Journal Article EditorArchives Of Environmental And Occupational Health Nov 2012 - PresentReview articles for journal publication
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Founder And Principal ConsultantMedhealthwriteconnect Oct 2023 - PresentEstablished and lead a consulting organization specializing in the medical device and in vitro diagnostics (IVD) industry. Provide expert guidance throughout the entire device life cycle—from development to post-market surveillance—ensuring compliance, quality, and regulatory alignment in the healthcare and biomedical sectors.
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Healthcare And Biomedical ConsultantMedhealthwriteconnect Feb 2015 - Sep 2023Serve as a Healthcare and Biomedical Consultant, offering a broad range of services such as medical education, technical writing and editing, and internal reviews.
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Cer Medical Writing Team LeadMedicept Inc. Jan 2023 - Aug 2024Boston, Ma, Us -
Medical WriterMedicept Inc. Jun 2022 - Dec 2022Boston, Ma, Us
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Senior Medical WriterMedtronic Sep 2023 - Mar 2024Minneapolis, Mn, Us -
Senior Cer Medical WriterMerit Medical Systems, Inc. Oct 2022 - Oct 2023South Jordan, Utah, Us -
Adjunct Public Health ProfessorUniversity Of Phoenix Jun 2010 - Jan 2023Phoenix, Az, UsOnline and on-campus instructor; currently teaching: Paradigms of Health , Elements of Health and Wellness, Human Nutrition, and Health Science -
Principal Medical Writer And Project Manager Consultant At Bannick LlcC4 Technical Services Jun 2020 - Feb 2021Eagan, Minnesota, Us -
International Regulatory Affairs Consultant IiiApple Jun 2020 - Oct 2020Cupertino, California, Us• Project Lead: create/revised departmental procedures to improve operations or to reflect changing regulatory requirementso Creation of new clinical evaluation process/SOPs, current CER/CEP/LSP/PMS/PMCF/SSCP templates, and work instructions.o Assisted in creating new QMS Processes for regulatory compliance, and prepare, execute and write up internal/external audits. - Resolved outstanding TUV notifying body audit findings (MDSAP) concerning pre-market and post-market regulatory & compliance issues. • Created and developed CERs for EU MDR Transition/Revisions for 2 product lines for Apple Watch 6 software – class IIa• Identified and performed gap assessment/analysis & strategy for clinical evaluation/compliance documentation with relevant international standards• Conducted gap assessment/analysis of Post Market Clinical Follow Up (PMCF) process -
Cer Medical WriterRegulatory And Quality Solutions Llc (R&Q) Dec 2018 - Jun 2019Monroeville, Pa, UsMEDDEV 2.7.1 rev 4 and EU MDR CER documentation -Preparing, writing, editing, and reviewing regulatory documents (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) in compliance with procedures, internal and external guidelines for medical device manufacturers - Class IIb, and III device -Searching and screening literature, performing literature reviews for specific medical devices -
Medical Writer/Clinical Research ScientistAmicus Therapeutics Jun 2014 - Dec 2014Princeton , Nj, Us- Prepare, assemble, write, and review the analyses and documentation at any point in the product development of clinical trials (Ph. I – IV) and corresponding submissions to regulatory authorities- Contributed compositions of analyses and documentation needed for submissions to regulatory authorities (e.g., Clinical Study Reports, Appendices, Investigative brochures, Protocols, Amendments)- Knowledge of ICH Guideline for Industry E3, E6, and E9- Knowledge of FDA Quality Systems and Reporting (21 CFR 11, 20, 21, 26, 50, 54, 56, and 58); GXP (GCP, GLP, cGMP, etc); GQA; RA; PV -
Quality Assurance And Compliance Complaint Specialist IiDepuy Synthes Feb 2013 - Apr 2014Raynham, Ma, Us- FDA Quality System and Medical Device Reporting regulations (21 CFR 11, 20, 803, and 820; ISO13485, 9001) - Regulatory filings: MDR reporting, MDR determination, PMA, 510(k) PMA supplements, IDE's, and IRs- Regulatory Affairs, Quality Assurance, Quality Systems, Complex Medical Products and Technologies, Combination Products, Drug Delivery Systems, and Post Market Research/ Pharmacovigilance -
Graduate Research AssistantUniversity Of Medicine And Dentistry Of New Jersey Dec 2011 - Aug 2012UsProject: Looking at the effectiveness of commercial weight loss program, the nutritional aspects, and the consumer’s ability to maintain weight loss long-term -
Product Surveillance Quality Associate AnalystBaxter Healthcare Oct 2010 - Jul 2011Deerfield, Illinois, UsPerform Retrospective review of Renal MDR Reportable decisions/complaint coding decisions and remediation -
Clinical Research AssistantRosalind Franklin University Of Medicine And Science Dec 2009 - Jul 2010Project: To determine if and why adolescent rats exhibit enhanced activity of VTA dopamine cells compared with adults
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Forensic ChemistHouston Police Department Dec 2007 - Jun 2008Houston, Texas, UsCriminal Analyst: Performed complex analysis on suspected controlled substances, testified as an expert witness, and helped modified sampling techniques to improve statistical analysis methodologies of controlled substances -
Graduate Research AssistantUniversity Of Arkansas For Medical Sciences Feb 2005 - Oct 2006Little Rock, Ar, UsGraduate Thesis Project: Assessing the Occupational Dermal and Inhalation Activities of Hairdressers
Evita Asumugha Skills
Evita Asumugha Education Details
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University Of Medicine And Dentistry Of New JerseyGeneral -
University Of Arkansas For Medical SciencesMaternal And Child Health With Biostatistics
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Rosalind Franklin University Of Medicine And ScienceMedicine
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University Of HoustonGeneral
Frequently Asked Questions about Evita Asumugha
What company does Evita Asumugha work for?
Evita Asumugha works for Fractyl Health
What is Evita Asumugha's role at the current company?
Evita Asumugha's current role is Clinical Safety Manager.
What is Evita Asumugha's email address?
Evita Asumugha's email address is a7****@****aol.com
What schools did Evita Asumugha attend?
Evita Asumugha attended University Of Medicine And Dentistry Of New Jersey, University Of Arkansas For Medical Sciences, Rosalind Franklin University Of Medicine And Science, University Of Houston.
What skills is Evita Asumugha known for?
Evita Asumugha has skills like Healthcare, Fda, Medical Devices, Research, Pharmacovigilance, Quality Assurance, Public Health, Public Speaking, Iso 13485, Community Outreach, Writing, Technology Needs Analysis.
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