What are the responsibilities and job description for the Medical Device Regulation Instructor position at BSI?
About the role:
The British Standards Institution (BSI) is hiring a Medical Device Regulation Instructor to design, development and deliver in-house and public training courses based on established medical device regulations using a wide range of delivery methods incorporating advanced learning techniques
Medical Device Instructor Responsibilities:
- Research into specific customer needs for training
- Manages training activities, ensuring all course content is covered and learning objectives are met
- Attain and maintain appropriate codes for training delivery in their area
- In-depth knowledge of Medical Device Directives and Regulations
- In-depth knowledge of In Vitro Diagnostic Device Directives Regulations
- Demonstrable experience and working knowledge of ISO 13485
- MD Risk Management, Creation of Technical Files for CE marking, CE marking of medical software, Process Validation as well as Post Market Surveillance and Vigilance
Education/Qualifications:
- Wide range knowledge of US FDA regulations
- In-depth knowledge of Medical Device Directives and Regulations.
- In-depth knowledge of In Vitro Diagnostic Device Directives Regulations
- Demonstrable experience and working knowledge of ISO 13485
- Audit experience to ISO 9001 and ISO 13485
What we offer:
BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.
Job Type: Full-time
Pay: From $86,600.00 per year
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Herndon, VA 20170: Reliably commute or planning to relocate before starting work (Required)
Work Location: On the road
Salary : $86,600 - $0
