Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. Inizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses.
Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes.
5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry Strong working knowledge of FDA Medical Device Reporting regulations (21 CFR 803) and complaint handling requirements (21 CFR 820.198) Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A Ability to evaluate complaint narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deaths Strong verbal and written communication skills with the ability to collaborate effectively across Quality, Regulatory Affairs, R&D, and Operations teams Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping Proficiency with MS Suite and complaint management systems such as SAP, TrackWise, or similar platforms Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field Mission: Support post-market surveillance and regulatory compliance efforts by reviewing product complaints, determining MDR reportability, and ensuring all adverse event submissions are completed accurately and in accordance with FDA requirements, including 21 CFR 803 and Quality System regulations.
Job Description: 5 years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry. Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A.
Job Title: MDR SpecialistDuration: 6 Months Contracts with possible extension/conversionLocation: Mundelein, IL 60060 (HYBRID, 3 Day Onsite and 2 Day Remote)Pay Range: $28/hr - $30/hrMust Haves: 5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry.
South Brunswick, NJ8 days ago
li> Evaluate deviations, investigations, change controls, out-of-specification (OOS) and out-of-trend (OOT) events, and CAPA activities, including root cause analysis and quality impact assessments. Required Experience/Skills for the QA Data Review & Compliance Specialist:- 3 - 5 years of experience in Quality Assurance, Quality Systems, Compliance, Auditing, or Data Review within a pharmaceutical, biotechnology, or regulated life sciences environment.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes.
We are seeking a Clinical Educator to deliver educational support to identified Healthcare Professionals and office staff within primary care and specialist facilities in the field of a designated disease state.
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
This is an opportunity to provide clinical leadership in developing RNAi therapeutics in client's rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology. The Senior Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies.
This is an opportunity to provide clinical leadership in developing RNAi therapeutics, rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology. While the primary focus responsibility will be as clinical lead physician on client's autoimmune liver disease programs, the role may support across a range of therapeutic areas and all stages of development may be required as pipeline assets evolve.
ARNP Fast Pace Health
ARNPHartford City, IN26 days ago
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: PRN Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: PRN - Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Louisville, KY26 days ago
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner- Up To $4,000 Relocation Assistance Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: PRN Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner / Physician Assistant - $5k Sign-On Bonus Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner / Physician Assistant – Join Our Team + $5,000 Bonus Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Belews Creek, NC26 days ago
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner / Physician Assistant - $2,500 Sign - On Bonus Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner / Physician Assistant (Float) Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner/Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
The Wexner Medical Center is rated as high performing in 17 out of 22 common procedures and conditions, including abdominal aortic aneurysm repair, aortic valve surgery, arrhythmia, COPD, colon cancer surgery, diabetes, gynecological cancer surgery, heart attack, heart failure, kidney failure, leukemia, lymphoma and myeloma, lung cancer surgery, pacemaker implantation, pneumonia, prostate cancer, spinal fusion, and transcatheter aortic valve replacement. Obtained or willing to attain (and maintain) in a time set by the Medical Director the following certifications as required by the Medical Director: DOT/FMCSA CME, MRO certification, Ohio BWC certified physician, USCIS designated Civil Surgeon, FAA AME, or any other certifications as required by future Service needs.
Our primary care physicians focus on Pediatrics, Family Medicine, and Internal Medicine while our specialty care physicians focus on the areas of Addiction Medicine, Cardiology, Gastroenterology, General Surgery, Infectious Disease, Obesity, Obstetrics/Gynecology, Orthopedics, Pain Management, Rheumatology, and Urology. This is a unique opportunity for a mission-driven physician executive to help shape the future of healthcare delivery in our communities strengthening medical staff engagement, advancing quality initiatives, and ensuring that clinical excellence remains at the core of Heywood Healthcare’s strategic direction.
Job DescriptionSentara Medical Group is currently seeking a Site Chief Hospitalist for Sentara Leigh Hospital in Norfolk, VA. Sentara Leigh Hospital is part of the Sentara Medical Group ( SMG ) Division of Hospital Medicine ( Chief Hospitalist ) who reports to the SMG Clinical Chief of Hospital Medicine and the facility VPMA, and provides leadership to the Hospitalist program in their facility. Bike, swim, sail, kayak, fish, or just relax on our miles and miles of sandy beaches or catch a bite to eat and listen to music at Norfolk's Waterside District.
Honolulu offers stunning natural beauty, world-class beaches, hiking, year-round outdoor activities, rich cultural heritage, and a welcoming, diverse community. Collaborative Team: Work with a diverse, skilled, and supportive group of providers who value teamwork and mutual respect.
Sparks, Nevada23 days ago
Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. They coordinate and support worldwide product registration requests, interface with global international regulatory and marketing contacts to support regional registration requirements and develop/maintain department procedures for international product registrations.
The Regulatory Affairs Specialist 1 will independently monitor their workload intensity and track deadlines to ensure prompt submission and/or completion and proper regulatory reporting and compliance deliverables are met, including recording and reporting requisite metrics for CTO leadership and departmental stakeholders. Collaborating directly with investigators, sponsors, and other key stakeholders within Yale CTO, as well as colleagues across the research enterprise, this role participates in the advancement of critical strategic objectives that promote effective, efficient, and compliant management of Cancer Center clinical research studies.