Post Market Surveillance Analyst

2 weeks ago

Doylestown, United States A-Line Staffing Solutions Full time
Job DescriptionJob Description

Post Market Surveillance Analyst
Remote
34.72/hr W2

Responsibilities

•         Conduct post market product data analysis and aid in creating necessary post market documentation such as post market surveillance plans and reports

•         Ensuring the adequacy of the documentation of post market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required.

•         Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.

•         Reviews and continuously executes the post market surveillance process. Extracts monthly post market quality data and helps in update of PMS reports

•         Performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection.

•         Summarizes trends, signals, and escalations.

•         Ensures appropriate identification and governance of complaint coding schemes. Links post-market quality systems to risk management files as appropriate.

•         Completes projects/other duties as assigned. Provides support during external and internal audits of the post market surveillance processes.

Skills and Competencies

•         Excellent written and verbal communication skills

•         Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment

•         Project management skills and the ability to maintain excellent electronic records

•         Intermediate to advanced MS excel skills (Pivot tables, Vlookup, formulas).

•         Ability to effectively collaborate with team members across functional areas

Qualifications and Experience

•         Bachelor’s degree in mathematics, engineering, business or related field

•         An advanced degree (MBA or MS) and a concentration in a technical, scientific, engineering or related field is preferred

•         Minimum of 2 years of relevant business experience

•         An understanding of basic statistical analysis software packages (SAS, R, SPSS, SQL) is preferred.

•         A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics is required.

•         Demonstrated ability to identify issues in post-market surveillance, complaints and service is preferred.

•         Experience with analysis and signal detection in a large data set is preferred.

•         Understanding of Risk Management is preferred.

•         Prior experience in the medical device industry or an FDA regulated environment is preferred.

•         Experience with Complaint Management System and technical documents is preferred.

If you're ready to unleash your expertise and drive digital innovation forward, reach out to Brett Middleton at bmiddleton@alinestaffing.com or simply apply to this posting. Let's shape the future of data together

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