Medical Devices Specialist
Há 1 mês
Job Summary:
We are seeking a highly skilled Medical Devices Specialist to join our team at Astrolabe - Medical. The ideal candidate will have a strong understanding of medical devices and regulatory directives, as well as excellent communication and interpersonal skills.
Key Responsibilities:
Compile, review, and submit applications for use, including CE marking, FDA, ISO 13485, INFARMED, UKCA, and MDSAP.
Actively research and analyze scientific data to ensure compliance with regulatory requirements.
Collaborate with partners, consultants, manufacturers, scientists, and health professionals to achieve project goals.
Lead and manage regulatory audits, and liaise with regulatory officials and consultants.
Develop and implement quality management systems, and perform training management and SHST management.
What We Offer:
A positive work environment with a growing company.
Salary commensurate with proven experience, and work-related training opportunities.
Health insurance and other employee benefits, including a meal card and free parking.
A high-responsibility position with opportunities for professional growth and development.
Requirements:
Excellent understanding of medical devices and regulatory directives.
Proficient English language skills, both written and spoken.
Proactive and action-oriented, with good communication and interpersonal skills.
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