- Generally requires a bachelor’s degree in a related science or engineering discipline and 4-5 years of relevant professional or technical experience of increasing responsibility and difficulty in assignments or the equivalent combination of education and experience.
- In depth knowledge of applicable regulations and requirements (e.g. ISO 13485, global medical device requirements, IEC 60601-1, IEC 80601-2-60, IEC 61010-1, ISO 14971, USA National Electrical Code, Canadian Electrical Code, and state and federal requirements).
- Strong interpersonal skills to build strong rapport with cross-functional project team members, external agencies and government regulatory agencies.
- Solid understanding of the purpose, requirements, and trends of regulations for medical device regulatory compliance.
- Ability to work independently with minimal supervision and in a team environment.
- Demonstrated ability to communicate effectively in oral, written, and illustration form.
- Proficiency in Microsoft Office; Outlook, Word & Excel; working knowledge of relational database software.
- Previous experience in the medical device industry is preferred.
- Regulatory Affairs Professional Certification (RAC) preferred.
- Ability to read, analyze, interpret common scientific and technical journals and legal documents, and train others in regards to regulatory requirements.
- Intermediate project management skills and experience with the ability to manage regulatory projects effectively.
Drug Screen and Background Check required.
A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. In addition, A-dec will not discriminate against applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another. *VEVRAA Federal Contractor”