Post-Market Surveillance Expert
hace 16 horas
Company Overview
MicroPort Orthopedics S.A. is a leading innovator in orthopedic solutions, dedicated to helping patients regain full function faster. Our commitment to advancing medicine and celebrating innovation drives our mission to be the fastest-growing industry powerhouse.
Job Description
We are seeking an experienced Post-Market Surveillance (PMS) Engineer I to join our team. The successful candidate will conduct all necessary PMS activities, including product complaint analysis, review of international registries, literature reviews, and clinical research summaries.
Responsibilities:
- Conduct PMS review team meetings and facilitate discussions.
- Analyze product complaints and determine trends.
- Review and analyze international registries and governmental databases.
- Assist with new product submissions and license renewals.
- Provide support to Product Development Engineers.
- Organize and conduct PMS meetings.
- Provide key analysis of product safety.
- Conduct literature searches and MAUDE database searches.
- Routinely update Clinical Evaluation Reports.
Required Skills and Qualifications:
- Familiarity with basic orthopedic knowledge.
- Strong leadership skills and analytical abilities.
- Excellent communication and technical writing skills.
- Entry-level engineering background and independent research skills.
- Ability to balance multiple projects and timelines.
Experience Requirements:
- Minimum 1 year of related experience, including internship and/or research experience.
- Some experience in the medical device industry preferred.
Education Requirements:
- Bachelor's Degree in Science/Engineering/Technical or related degree required; Master's Degree preferred.
- Design, material science, statistical analysis, and technical writing courses ideal.
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