Technical Specialist, Clinical Evaluation Specialist & Scheme Manager - SaMD
BSI · United States · 1 wk ago
RemoteRemoteEngineeringFull-time
About the role
We exist to create positive change for people and the planet. Join us and make a difference too!
Key Responsibilities & Accountabilities
- Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits to support EC Certification.
- Manage client projects, acting as their primary contact and after satisfactory assessment, to make certification recommendations for CE, UKCA and ISO 13485 certificate issue to ensure compliance with required certification, timely delivery of services and client satisfaction.
- Perform unannounced visits to medical device manufacturers globally as a technical expert to check on compliance with certification.
- Work with Line Manager and other team leaders as required to provide reviews within area of expertise.
Essential Criteria
- 4 or more years of Software Medical Device experience in a technical capacity, preferably within product design, development and/ or testing.
- Interpretation and applications of International and National standards for the design, development and regulation of software medical devices.
- Understanding of Risk Management and FMEA of Software Medical Devices.
- Broad technical understanding of medical devices.
- Understanding of companies operating in these spaces and current industry trends.
Qualifications
- Degree educated (Bachelor’s minimum or equivalent) relevant to medical device design, development, manufacture and use i.e. electro-mechanical, electronic/electrical, biomedical engineering, computer science, medical physics or similar.
Benefits
- Competitive total reward package.
- Independent and varied job in an international environment.
- Flexible working hours.
- Ongoing training and development.
Pay
Salary differs per country according to various factors. If you reside in another country, you'll be notified of the salary range by the recruiter.
Schedule
Flexible working hours.
Skills
Technical skills in medical device software, interpretation of standards, risk management, and medical device understanding.
Benefits
- 20-days annual leave.
- Bank holidays.
- Medical, dental, vision, and life insurance.
- 401(K) with company contribution.
- Short-term and long-term disability.
- Motherhood leave.
- Paid parental leave.
- Paid bereavement leave.
- Learning and development opportunities.
- A wide range of flexible benefits that you can tailor to suit your lifestyle.