Senior Medical Safety Analyst at Abbott

Ballymote, County Sligo, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor of Science, a Health science related background is a plus, such as dietitian, pharmacist, nurse etc
RAC certification a plus
2-3 years Medical Device experience in activities such as aggregate data review, Risk Assessment, DFMEA review, and patient safety
Data analytics / strong excel, PowerBI and/or data visualization skills
Medical knowledge to apply critical thinking and data analysis to Medical Safety data and/or Medical Device risk assessments
Basic understanding of Global Medical Device regulations (primarily EUMDR, MedDEV), clinical research, and international guidelines/ standards related to medical devices (ISO, GSPR, MDGC etc.)
Willingness to learn other applicable Medical Device regulations, standards and guidelines
Drive to adhere to standard operating procedures (SOPs)
Strong ability /experience in presenting medical and scientific training/ data orally and in writing
Computer proficient (Windows, Word, Excel)
Enjoys working in a collaborative environment and with a multidisciplinary, Global team
Works independently

Responsibilities

Create and present medical safety related analyses, reports, and/or assessments orally and/or in writing within/ outside the Medical Safety and Surveillance department
Gather, critically analyze, and present findings from Medical Safety and Surveillance complaint data on a periodic basis, including tracking and trending activities
Ensure adherence to departmental standard operating procedures (SOPs), and draft new SOP as needed
Develop Medical Safety and Surveillance training materials and provide training to a broad international audience
Write or assist in preparing, completing literature or website searches and data analysis for regulatory documentation supporting medical device registration
Conduct periodic literature searches, summarize findings and present information to a cross-functional team
Act as a back up to colleagues on day-to-day medical device complaints processing and conduct medical follow up calls to customers as needed to obtain adverse event and/or complaint details
Determine complaint reportability to the competent authority; drive on-time vigilance reporting within regulatory time-frames
Other duties/projects/support as assigned
Review, assess, and summarize medical device complaint information for complex investigations and risk assessments
Critically assess aggregate safety data from medical devices and communicates findings to internal stakeholders
Independently creates and delivers device medical safety training to a Global audience
Drafts documentation, including data reviews, clinical evaluations, literature reviews and standard operating procedures

Skills

Medical Device Complaints

Safety Surveillance

Risk Assessment

Aggregate Data Analysis

Clinical Evaluation

Literature Review

SOP Drafting

Training Delivery

Trend Analysis

Signal Detection

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees