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 114,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Senior Project Manager, Post-Market Safety Evaluation
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,nutritionalsand branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
In this role, you will provide technical and strategicexpertiseatthe post-market phase of product life cycles. Reviews/manages Post-Market Surveillance (PMS) Plans, Periodic Safety Update Report (PSUR) and PMS Report and interacts with various cross-functional teamsin order toassistin strategy, plans, and project deliverables. Must be able to effectively manage multiple projects and timelines.
With minimum supervision, collaborates with medical writers to create andmaintainPMS plans, PSURs and PMS Reports for Abbott products. Identifiesappropriate sourcesof relevant data, interpret,evaluateand incorporate information from various sources including literature, clinical data, and medical references.
Facilitates communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, Product Performance Group (PPG), Sales and Marketing, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers.
BachelorsDegree (± 16 years), In related field., ,an equivalent combination of education and work experience
Preferred Qualifications:
Bachelor's degreerequired, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred. Minimum of6+years of related work experience with an understanding ofspecifiedfunctional area, or an equivalent combination of education and work experience. May consider candidates with lessexperiences.
Understanding ofregulations, standards and guidelines related to medicaldevicesclinical studies and quality systems, including: MDR 2017/745; MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
Experience in post-market surveillance, risk management, clinical research, or regulatory affairs in medical device or pharmaceuticals industry
The base pay for this position is
$86,700.00 – $173,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Clinical Affairs / Statistics
DIVISION:
MD Medical Devices
LOCATION:
United States > Santa Clara : Building A - SC
ADDITIONAL LOCATIONS:
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: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf