Our Client - ELIQUENT Life Sciences - is seeking bilingual Medical Device Affiliate QMS Instructor / Consultants in Costa Rica.
The roles are home-based and require the ability to travel to client sites for delivery, or the ability to deliver through virtual technology.
We are seeking highly organized individuals who are self-starters, good communicators and are open to flexible work arrangements, seeking variety in the work they do.
Position Description A Medical Device Affiliate QMS Instructor / Consultant is responsible for planning and leading public training courses, and private courses for major clients related to quality system audits, development, deployment, remediation, and/or regulatory affairs activities such as submissions, clinical study, and post-market surveillance.
Instructors with consulting and/or audit skills may also have the opportunity to be involved in consulting and/or audit projects.
The role is primarily that of an individual contributor, although teamwork is expected.
Person Description Confident personality and competent in getting ideas across to others effectively Bilingual - English/Spanish Has demonstrated the ability to work in a team environment, especially when operating remotely Has a passion for patient safety through effective regulatory and quality activities Respects the contribution of all colleagues and facilitates consensus on tough issues Demonstrates flexibility in day-to-day working in the team and approach to unique client issues Basic Qualifications Bachelors degree in Engineering, Science, or life sciences-related field Evidence of progressively taking more responsibility and leading activities in their field Delivery of a significant number of workshops in a public, or private setting Industry Requirements Experience with medical device or in-vitro device manufacturing, interpretation, and application of codes, regulations, and standards, GMP Experience with quality systems planning and implementation, design control, and process validation Experience with submissions, remediation, clinical evaluation, post-market surveillance, risk management Experience with FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21CFR Part 820 and/or relevant EU Directives Experience with any of MDSAP; ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 a plus Travel Ability to travel extensively domestically (50% - 75%).
Occasional international travel may be required.