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At MicroPort, we relentlessly strive to master every detail of our medical solutions with the purpose of prolonging and reshaping the lives of patients everywhere. We welcome motivated and talented people who want to join our dynamic and inclusive company, working together to deliver meaningful medical breakthroughs. In order to accomplish this, we hold true to our core values of Quality, Integrity, Accountability, Efficiency, Innovation, Aspiration, Dedication & Collaboration. Come and join Team MicroPort!  

Why You’ll Love MicroPort

You will find our team atmosphere challenging and rewarding. In addition to working with a world-class team, receiving a competitive base salary. At MicroPort, we care about our employees and encourage them to make healthy lifestyle choices and embrace wellness opportunities to maintain their very best health and wellbeing.

Hours: Monday-Friday, 8:00am-12:00pm (flexible schedule available)

Overall Summary

This position is responsible for supporting the Clinical and Post-Market Surveillance (PMS) teams by assisting with department responsibilities.

Your duties will include:

• PSUR Preparation Support: Assist in drafting Periodic Safety Update Reports by compiling safety and performance data gathered through post-market surveillance activities. This includes preparing cover pages, executive summaries, and device descriptions
• Documentation Maintenance: Help update and maintain Post-Market Surveillance plans, and standard operating procedures (SOPs).
• Regulatory Alignment: Support the alignment of PSUR content with other technical documentation, such as Clinical Evaluation Reports (CER), and Summaries of Safety and Clinical Performance (SSCP).
• Regulatory Documentation: Maintain Trial Master Files (TMF) and essential documentation, ensuring adherence to Good Clinical Practice (GCP) standards.
• Observational Study Support: Assist requestors and coordinators in executing post-market clinical follow-up (PMCF) activities for established products, such as femoral stems or other orthopedic devices. 
• Data Management: Assist with quality review and document review for clinical trials or observational follow-up studies.
• Scientific Literature Review: Conduct systematic searches of scientific literature and public databases to identify new safety information.
•  Article Library: assist with published literature centralization project
•  Assist other departments as needed.

Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

About You

We might be a great match if you have:

• Competency skills include analytical thinking, problem solving, communication and interpersonal skills, technical writing, and teamwork. 
• Technical skills include understanding engineering and orthopedic terminology, Microsoft Office software, and the ability to learn relevant software systems.

YOUR EDUCATION

Required: HS Diploma or GED - Must be enrolled in or graduated from a four-year science / engineering / technical undergraduate program. 

Preferred: Bachelor’s Degree

YOUR EXPERIENCE

No related experience required