Note: The job is a remote job and is open to candidates in USA. BSI is a business improvement and standards company dedicated to creating positive change for people and the planet. They are seeking a Technical Specialist, Clinical Evaluation Specialist & Scheme Manager for Software as a Medical Device (SaMD) to manage CE marking schemes and provide technical expertise to healthcare personnel.
Responsibilities
- 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
- Act as technical support to the commercial team when required to support business development and marketing activities as it grows the customer base worldwide
- 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
Skills
- 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
- 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
- 20-days annual leave
- Bank holidays
- Medical, dental, vision, and life insurance
- 401(K) with company contribution
- Short-term and long-term disability
- Maternal 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
- Flexible working hours
- Ongoing training and development
Company Overview
Company H1B Sponsorship