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.
ARNP Fast Pace Health
ARNPGreens Fork, IN1 day 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: 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.
Brookville, 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: 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: 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 – 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.
Rocky Mount, 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 - $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.
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.
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.
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.
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.
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.
Salt Lake City, UT30+ days ago
li>Provide support to the CTSI to 1) ensure compliance with the NIH Public Access Policy for all articles associated with the CTSI, including assisting authors with the process, and 2) develop and refine programming (web materials, presentations, etc) to promote awareness of this requirement throughout the timeline of an investigator/author's involvement with any CTSI core(s). Open Date 04/30/2026 Requisition Number PRN44883B Job Title Regulatory Affairs Specialists Working Title QA/QC Navigator Career Progression Track P00 Track Level P2 - Developing, P1 - Entry Level Pro FLSA Code Professional Patient Sensitive Job Code?
p>Alternatively, will accept a Master's degree in Regulatory Affairs, Healthcare Policy, Healthcare Management, or related field and three (3) years of experience as a Senior Regulatory Affairs Specialist, International Regulatory Affairs Specialist, Regulatory Affairs Specialist, Regulatory Affairs Co-Ordinator, or related role where experience was gained, plus the special skills listed above. Requirements: Bachelor's degree in Regulatory Affairs, Healthcare Policy, Healthcare Management, or related field and five (5) years of experience as a Senior Regulatory Affairs Specialist, International Regulatory Affairs Specialist, Regulatory Affairs Specialist, Regulatory Affairs Co-Ordinator, or related role where experience was gained.
Rocky Hill, CT30+ days ago
on W2 (Without benefits) Job Description Responsibilities: Ensure that our customers and employees are fully informed about the health and safety characteristics of our products and raw materials and that all products marketed by Henkel Corporation are in compliance with all appropriate regulations (Federal, State, County, regional and/or local.) Provide timely assessments of developmental materials, including chemical materials and formulations, in order to assure that their health and safety, transportation, and disposal considerations are fully understood relative to business impact and customer satisfaction.
Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envistas internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Westminster, CO30+ days ago
p>This person will be joining a small, but mighty team and will have the opportunity to work on a variety of projects, focused on new product introduction, for the world's largest privately held spine company. Principal Duties and Responsibilities:
- Become a brand champion, owning regulatory activities for that brand, from new product introduction, to product changes and revisions, and international registration support.
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. Required Education and Experience:
Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered).