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Abbott · 7 hours ago

Senior Project Manager, Post-Market Safety Evaluation

Santa Clara, CA

Full-time

Onsite

Mid, Senior Level

$87K/yr - $173K/yr

4+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Project Manager, Post-Market Safety Evaluation will provide technical and strategic expertise at the post-market phase of product life cycles, managing various plans and reports while collaborating with cross-functional teams.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

H1B Sponsor Likely

Responsibilities

With minimum supervision, collaborates with medical writers to create and maintain PMS plans, PSURs and PMS Reports for Abbott products. Identifies appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references

Creates or participates in the PMS Plan/PSUR/PMS Report timelines. Actively manages timelines and project delays/risks, develops scenario’s and 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

Qualification

Post-Market SurveillanceRisk ManagementClinical ResearchRegulatory AffairsPMS Plans / PSURsMedical Device RegulationsProject ManagementEffective CommunicationInterpersonal SkillsAttention to Detail

Required

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

Minimum 4 years, Related work experience with a solid understanding of specified functional area

Broad knowledge and application of business concepts, procedures and practices

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

Learns to use professional concepts and company policies and procedures to solve routine problems

Works on problems of limited scope

Independent decision making required

Preferred

Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred. Minimum of 6+years of related work experience with an understanding of specified functional area, or an equivalent combination of education and work experience. May consider candidates with less experiences

Knowledge of PMS Plans / PSURs / PMS Report

Knowledge of CERs and related documents in accordance with MDR 2017/745

Understanding of regulations, standards and guidelines related to medical devices clinical 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, verbal and 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 to identify and adapt to shifting priorities and competing demands

Highly-developed interpersonal skills, and strong attention to detail

Company

Abbott

Glassdoor3.8

Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.

Founded in 1888

Illinois City, Illinois, USA

10001+ employees

https://www.abbott.com

H1B Sponsorship

Abbott has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2021 (1)