Clinical Risk Evaluation Project Manager
United States
– Minnesota
– Plymouth
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 109,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive.
Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier.
Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks.
We currently have a great opportunity for a Clinical Risk Evaluation Project Manager.
Location can be Plymouth MN, Maple Grove MN, Sylmar CA or Santa Clara CA.
WHAT YOU’LL DO
In this role, you will provide cross functional support to ensure the clinical benefits and potential safety/residual risk information of Abbott Medical device products are aligned and consistent across product documentation and throughout the life cycle of the device.
This process supports Abbott medical device business units (BUs) to enable conformity in product benefit risk assessments, consistent and aligned language between submission documents, and compliance with regulatory submission requirements.
The Clinical Risk Evaluation (CRE) Project Manager writes and manages product master files of clinical risks, anticipated adverse events/side effects, contraindications, warnings, precautions, critical warnings, restricted substances, incident reporting and intended clinical benefits.
The CRE Project Manager must be able to effectively manage multiple projects and timelines in a fast-paced and diverse environment.
Lead and participate in the clinical risk evaluation process; review available medical device and procedure related clinical and risk data throughout the product life cycle; Independently create and maintain Risk Evaluation Files (REFs) for Abbott medical device products; Lead Risk Alignment Committee (RAC) meetings and actively engage BU cross-functional stakeholders (Regulatory Affairs, Clinical Affairs, Medical Affairs, Clinical/R&D Engineering, Quality, Product Labeling, and others as relevant); facilitates and documents informed decision-making with corresponding rationale; Evaluate clinical safety data from all available sources, including Abbott sponsored and other clinical investigations, post-market experiences, complaint data, and scientific literature for anticipated AE frequencies; Review Global IFUs, clinical investigation documentation and physician training material, Risk Management Reports (RMR), Clinical Evaluation Report (CER), Periodic Safety Update Reports (PSURs) and Summary of Safety and Clinical Performance (SSCP) to ensure clinical risk information alignment between documents; Support global regulatory submissions; ensure ongoing, proactive communication and engagement with Regulatory Affairs and other relevant stakeholders during the submission process; Support business unit responses to queries from regulatory authorities, ethics committees or institutional review boards related to GRO-CRE clinical risk disclosure information; May participate in and support audits, root cause analyses, preventive or corrective actions, and effectiveness monitoring, as requested by management; Maintain working knowledge of assigned products and therapeutic areas; Identify appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, complaints, clinical data, and medical references; Provide oversight to vendors/CROs, manage timelines, mitigate project delays/risks and escalate to management as appropriate; Act as a mentor to less experienced staff; Provide and implement innovative ideas and solutions to Clinical Risk Evaluation group for continuous process improvement; Support updates and revisions as necessary to Clinical Risk Evaluation DOPs/SOPs, WI, and templates, and provides input to cross-departmental procedures describing risk information; Responsible for compliance with applicable corporate and divisional policies and procedures.
Ensures compliance to applicable regulations and guidelines (including ISO13485, ISO14155, ISO14791, MEDDEV 2.7/1 Rev.4, EU MDD/AIMDD/MDR and MDCG/FDA guidance documents).
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
Bachelors Degree Biomedical or medical degree or an equivalent combination of education and work experience Minimum 5 years of experience in a medical device clinical research, medical writing, or combination of these skills
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career.
We offer:
Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
JOB FAMILY:
Clinical Affairs / Statistics
DIVISION:
AVD Vascular
LOCATION:
United States > Santa Clara : Building A
– SC Floor-2
ADDITIONAL LOCATIONS:
United States > Minnesota > Plymouth : 5050 Nathan Lane N, United States > Sylmar : 15900 Valley View Court
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
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: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link
– Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Posted 3 Days Ago
Full time
30984012
About Us
Abbott is about the power of health.
For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.
With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life.
Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people.
They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.