Remote Technical Specialist, Active Medical Devices

BSI; United States; Remote; USD 78,000 - 104,000; Full time

Benefits offered by this job

Flexible working hours

Ongoing training and development

Job summary

BSI is seeking a Technical Specialist & Scheme Manager for Active Medical Devices on a global homebased role. You will review regulatory documentation, manage certification activities, and provide strategic support across CE marking schemes for medical devices.

Ideal candidates have 4+ years in healthcare product fields, a relevant degree, and familiarity with EU MDR/UK MDR. Strong communication and project management skills are essential for success in a global, flexible work environment.

Qualifications

• Four years’ professional experience in healthcare products or related activities
• Bachelor’s or higher degree in a discipline relevant to medical device industry
• Familiarity with Medical Devices Regulation (EU)2017/745 and/or Medical Devices Directive 96/42/EEC is an advantage
• Awareness of IEC 60601 and ISO 14971 risk management standards
• Understanding of design control and risk management principles
• Strong interpersonal communication skills

Responsibilities

• Review and evaluate medical device technical and clinical documentation for compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2012 schemes
• Manage certification activities for a portfolio of medical device manufacturers, including auditing requirements and CE certifications
• Provide regulatory, operational and strategic support to scheme managers and product specialists
• Provide leadership and mentoring in areas of medical device competence

Skills

Regulatory knowledge

Interpersonal communication

Project management

English writing

Education

Bachelor's or higher in a relevant discipline

Job description

BSI is seeking a Technical Specialist & Scheme Manager for Active Medical Devices on a global homebased role. You will review regulatory documentation, manage certification activities, and provide strategic support across CE marking schemes for medical devices.

Ideal candidates have 4+ years in healthcare product fields, a relevant degree, and familiarity with EU MDR/UK MDR. Strong communication and project management skills are essential for success in a global, flexible work environment.