Ade Ajibade Email & Phone Number

Nussloch, De

In 2021 I transitioned to a Regulatory Affairs Specialist role where I am responsible for regulatory assessments, technical file maintenance and international registrations for digital pathology IVD imaging and software products used in research and clinical oncology environments. In this position, I work cross-functionally with product management, sustaining project teams and global regulatory teams.My current responsibilities include:• Responsible for generation and maintenance of regulatory files.• Serve as a Regulatory Affairs representative on sustaining projects.• Collaborate globally and cross-functionally (e.g., Quality Assurance, Research & Development, Product/Program Management) to conduct regulatory assessments and sustain current and market expansion regulatory registrations under IVDD, US FDA and other global regulations.• Support senior regulatory staff with complex regulatory submissions.• Collaborate with global teams to meet business goals and regulatory milestones for product commercialization.• Stay on top of new and evolving regulatory intelligence and maintain solid understanding of relevant regulations, guidance, and requirements.• Integrates Danaher Business System principles and practices including participation in continuous improvement initiatives, solving problems and aiming for measurable results.As I continue to grow in this field, I have gained working understanding and knowledge of both U.S. and international regulations, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485 Medical devices — Quality Management Systems and Medical Device Regulations (MDR) or In Vitro Diagnostic Regulations (IVDR).

Franklin Lakes, New Jersey, Us

In 2017 I transitioned to a Senior Regulatory Specialist at Becton Dickinson which had recently acquired CareFusion. In my role I have assisted in the growth of my team in training and developing new employees to create, populate and submit Electronic Medical Device Reporting (eMDRs). In this leadership role, I have contributed significantly to the hiring and training process of 6 new team members as the FDA continues to update guidelines and procedures.In addition to accurately submitting files to the FDA, I also have to be in active communication with the nursing team who are in direct communication with the customer and are responsible for utilizing their medical knowledge to populate complaint files. On the initial review of a complaint file, I review the document to make sure it’s reportable and if so I generate an “eMDR”. After populating all the required fields in the eMDR, I review and assign the file back to the nurse who originally created the complaint file. After conducting a thorough review from both parties, the file is formally submitted to the FDA.While working in collaboration with the nursing team, I have expanded on my teamwork skills and ability to set clear expectations and guidelines set forth by the FDA.Additional responsibilities include:• Complete global complaint handling and adverse event reporting activities.• Provide support for internal quality audits of complaint files / MDR documentation.• Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability.• Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information.I understand the medical device field is expanding and I look forward to see what innovations come next.

San Diego, Ca, Us

After moving from Chicago to San Diego, I was lucky enough to join CareFusion as a Regulatory Specialist. CareFusion is a subsidiary of Becton Dickinson specializing in two areas: reducing medication errors and prevention of health care-associated infections. The organization was involved manufacturing disposable sets and instrument devices.With a direct report to the VP of Quality Affairs I worked on a team of two acting as a direct liaison between the U.S Food and Drug Administration and CareFusion. In my role I was tasked with collaborating with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability. In working with the “FDA”, I understand how imperative it is to be organized, timely with MDR delivery and clear in documentation of customer complaints. CareFusion’s commitment to reducing medication errors was always centered in my work and drove my motivation to never submit late files to the FDA.

Advocate Medical Group is an organization specializing in:• Understanding a new diagnosis or complicated medical condition• Providing coordination and oversight for patients and families• Taking charge and managing a medical crisis or change in health• Communicating with medical staff, getting answers to questionsDue to my healthcare background, Advocate Medical Group hired me because they considered me a valuable asset to the overall Registration Specialist Team.As a Registration Specialist I was tasked with these duties:• Responsible for fielding and resolving patient concerns and inquiries in the Advocate Patient Contact Center, specializing in new patient registration and insurance changes. • Carefully screen calls and contacts to ensure appropriate handling of appointment requests for providers in various specialties, including Internal Medicine, Pediatrics, Family Practice, and select others, as well as nurse schedules.• Electronically verify insurance coverages using the Experian (MPV) insurance date system.• Specialize in collecting demographic and insurance information for new Advocate patients or patients updating their existing information, and accurately entering this information into the IDX scheduling system.• Offer prompt and efficient telephone assistance to Advocate patients for a variety of additional services, including: booking, canceling, and rescheduling patient appointments, clinic visits, immunizations, minor procedures, annual physicals/well visits, and urgent/same day visits.• Provide general information regarding setting and paging of Physicians. • Update patients on Physician prescribed refill and lab requests. • Apply knowledge of a variety of general coverage rules, including commercial, government, and managed care.

As a Certified Nursing Assistant (CNA) I had three years’ experience working in the private care industry for geriatric patients. My daily duties were:• Planned, prepared and served meals and snacks according to prescribed diets.• Administered prescribed oral medications under written direction of physician or as directed by home care nurse. • Managed bedside and assisted in personal hygiene, toileting and ambulation.• Prepared and maintain records of client development.• Instructed and inform clients on health care issues regarding hygiene and nutrition.• Reported any variation in client’s physical or mental health to fellow care providers.I developed an open line of communication by updating family members of any of the patients healthcare plans. In addition, I was responsible for taking vital signs such as temperature and blood pressure every day to keep tabs on the health of the patient. Also, I took the patients pulse, weight, and pain level every day on time according to their schedule and reported them accurately.After tending to the patient wounds. I cleaned them, dressed them, and ensured that they are healing properly by preventing bed sores and turning them often and regularly.