
Senior Biomedical Solutions Specialist
4 days ago
About the Role:
We are seeking a skilled Biomedical Engineer to collaborate with medical device and healthcare companies to deploy eQMS solutions. As part of our team, you will conduct training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
Main Responsibilities:
- Deploy eQMS solutions to medical device and healthcare companies across various sectors.
- Develop and deliver comprehensive training programs to ensure seamless adoption of eQMS systems.
- Serve as a subject matter expert in compliance standards (ISO 13485, FDA 21 CFR Part 11) to guarantee adherence to regulatory requirements.
- Provide clinical application support and liaison services to hospitals, laboratories, and device manufacturers to address technical queries and resolve issues efficiently.
- Gather customer feedback and work closely with product & engineering teams to drive feature enhancements and improve overall user experience.
- Support clients during audits, inspections, and compliance reviews to ensure a smooth process.
Required Skills and Qualifications:
- Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or an equivalent field.
- Prior experience working with medical devices, hospital equipment, or clinical applications is highly valued.
- Proficiency in compliance frameworks: ISO 13485, FDA 21 CFR Part 11, GxP, MDR (desired).
- Strong communication and interpersonal skills to effectively train, mentor, and support healthcare professionals.
- Ability to analyze complex problems and work collaboratively within cross-functional teams.
- Excellent presentation and public speaking skills to engage diverse stakeholders, including medical professionals and regulatory staff.
Key Soft Skills:
- Analytical mindset with strong documentation skills to maintain accurate records.
- Empathy and patience when interacting with clinical staff and clients.
- Collaborative attitude to work effectively with diverse stakeholders.
- Adaptability to handle regulatory challenges and evolving customer needs.
Language Requirements:
- Fluency in English (written & spoken) is mandatory.
Benefits:
This role offers a unique opportunity to grow professionally, develop expertise in eQMS solutions, and contribute to the success of our organization. If you possess the required skills, qualifications, and passion for delivering exceptional results, we encourage you to apply.
Others:
Please note that this job description may be subject to change based on business needs.
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