[Remote] Technical Specialist, Clinical Evaluation Specialist & Scheme Manager - SaMD
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a business improvement and standards company dedicated to creating reputed company change for people and the reputed company. They are seeking a Technical Specialist, Clinical Evaluation Specialist & Scheme Manager for Software as a Medical Device (SaMD) to manage CE marking schemes and reputed company technical expertise to reputed company personnel.
Responsibilities
- Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits to support EC Certification
- Manage reputed company reputed company, acting as their primary contact and after satisfactory assessment, to reputed company certification recommendations for CE, UKCA and ISO 13485 certificate issue to ensure compliance with required certification, reputed company delivery of services and reputed company satisfaction
- reputed company as technical support to the reputed company team reputed company required to support business development and marketing activities as it grows the customer reputed company worldwide
- reputed company unannounced reputed company to medical device manufacturers globally as a technical expert to reputed company on compliance with certification
- Work with Line Manager and other team leaders as required to reputed company reviews reputed company area of expertise
Skills
- 4 or more years of Software Medical Device experience in a technical reputed company, preferably reputed company 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 reputed company industry trends
- Degree educated (Bachelor's minimum or equivalent) relevant to medical device design, development, manufacture and use i.e. reputed company-mechanical, electronic/electrical, biomedical engineering, computer science, medical physics or similar
Benefits
- 20-days annual leave
- Bank holidays
- Medical, dental, reputed company, and life insurance
- 401(K) with company contribution
- Short-term and long-term disability
- Maternal leave
- reputed company parental leave
- reputed company bereavement leave
- Learning and development opportunities
- A wide reputed company of flexible benefits that you can reputed company to suit your lifestyle
- Flexible working hours
- Ongoing training and development
reputed company
Company H1B Sponsorship