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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.

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, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Job Description

In this role, you will provide technical and strategic expertise at the 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 teams in order to assist in 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.

+ Creates orparticipatesin the PMS Plan/PSUR/PMS Report timelines. Actively manages timelines and project delays/risks, developsscenario’sand recommendations for management. Ensures project expenditures are within budgetary guidelines

+ 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.

+ Maintains update-to-date understanding and experience of clinical / PMS data and risk management.

+ Contributes to the development and maintenance of PSUR/PMS Report DOP/SOP and associated documentation, provides input to cross-departmental SOPs and DOPs as needed.

Required Qualifications:

+ BachelorsDegree (± 16 years), In related field., ,an equivalent combination of education and work experience

+ Minimum 4 years, Related work experience with a solid understanding ofspecifiedfunctional area.

+ Broad knowledge and application of business concepts,proceduresand practices.

+ Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

+ Learnsto use professional concepts and company policies and procedures to solve routine problems.

+ Works on problemsoflimited scope.

+ Independent decision makingrequired.

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.

+ Knowledge of PMS Plans / PSURs / PMS Report.

+ Knowledge of CERs and related documentsin accordance withMDR 2017/745.

+ 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.

+ Effective written,verbaland presentation skills in the area of technical/clinical applications.

+ Familiar with IMDRF terminology/codes and adverse event reporting is preferred

+ Project management experience is preferred.

+ Experience in post-market surveillance, risk management, clinical research, or regulatory affairs in medical device or pharmaceuticals industry

+ Demonstrated ability toidentifyand adapt to shifting priorities and competing demands.

+ Highly-developedinterpersonal skills, and strong attention to detail.

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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]