Clinical Evaluation, Project Manager Clinical Scientist at Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritionals and branded generic medicines. Our 114000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:The function of a Clinical Evaluation Project Manager supporting our Structural Heart Products combines understanding of scientific and research methodology medical device regulations and guidelines and product knowledge to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the European Commission Guidelines on Medical Devices: Clinical Evaluation : A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC (2016)requirements (MEDDEV 2.7/1 Rev 4) and EU Regulation 2017/745.The CER PM is recognized as a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.g. CEP PMS/PMCF Plan SSCP and PSUR and CER). As such this person has oversight of one or more medical writers guiding the development or update of CERs and CER-related addition the CER PM will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety performance adverse events and risk/benefit profile of a device or devices. Moreover the CER PM may be requested to contribute to other activities such as risk assessment and management and review of informational documents like the Instructions for Use. The CER PM will sit on core team product development CER-related SOP development and revision and interact with regulatory agencies representatives as needed.The role of PM plays a significant part in new product development as well as in the subsequent evaluation of the safety and performance of a device over its lifecycle. The position reports to the Sr. Manager of Clinical Evaluations Global Regulatory Operations.Main Responsibilities:Manage medical writers efforts in writing and editing of scientific content of deliverables and the timelines of these documentsCreates manages or participates in timelines of deliverables by using appropriate project management tools.Clearly and timely communicates the timelines project risks and risk mitigation strategies with cross functional teams and medical writersInterprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature and staying abreast of current clinical practiceWrite and edit as needed Clinical Evaluation Plans and Clinical Evaluation Reports and other clinical CER deliverables.Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.Facilitate communication and exchange of documents between stakeholders (e.g. internal personnel such as Regulatory Affairs R&D Clinical R&D Sales and Marketing Library Services Quality Engineering Clinical Affairs Risk Management Project Management as well as external vendors such as CROs Medical Writers and Reviewers).Provide strategic guidance on regulatory requirements pertaining to clinical data and clinical evaluation to new product development teams and sustaining teams.Participate in and support audits and responses to audit findings as appropriate in root cause analysis preventive or corrective actions effectiveness monitoring and other quality metrics.Function independently as a decision-maker on CER-related regulatory issues and must assure that deadlines are met.Execute projects within budgetary guidelines.Required Qualifications:Associates Degree ( 13 years)Minimum 7 yearsPreferred Qualifications:A college degree (Bachelors); in the life sciences (nursing medicine biomedical engineering)Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissions3-5 years of experience in clinical research quality systems or regulatory experience in medical deviceUnderstanding of regulations standards and guidelines related to medical devices clinical studies and quality systems MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485Effective written verbal and presentation skills in the area of technical/clinical applicationsStrong command of medical and surgical terminologyProject management and/or management of people experienceDemonstrated ability to identify and adapt to shifting priorities and competing demandsHighly developed interpersonal skills and strong attention to detail with accountability for ensuring deliverables are met on timePost graduate degree (Masters or Doctorate) preferred in the life sciences (nursing medicine biomedical engineeringExperience in structural heart / structural intervention devicesCertification is a plus (e.g. RAC and PMP)MD / PhD/RN/Pharm D with good written skills The base pay for this position is $75300.00 $150700.00In specific locations the pay range may vary from the range posted. JOB FAMILY:Regulatory Operations DIVISION:MD Medical Devices LOCATION:United States > Maple Grove : 6820 Wedgwood Road N. ADDITIONAL LOCATIONS:United States > Santa Clara : Building A - SC WORK SHIFT:Standard TRAVEL:No MEDICAL SURVEILLANCE:No SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: Experience:IC Key Skills CSS,Cloud Computing,Health Education,Actuary,Building Electrician Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 75300 - 150700