Operations Specialist, Regulatory Affairs
Requirements:
- B.S./B.A. (4-year Degree) and/or an equivalent combination of education and experience/background in life sciences, technical (engineering) or related field.
- RAPS (RAC) Certification is preferred.
- 2+ years of Medical Device Regulatory Affairs experience.
- Working knowledge of International Regulations (e.g., US FDA 21 CFR 820, EU MDR 2017/745 and IMDRF/GHTF.) required.
- Experience in prioritizing and exercising sound judgment in RA & QA matters is required.
- Bachelor's Degree and 1 year experience in the medical device industry
- Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)
- Strong written and verbal communication skills
- Proficient project management skills.
- PC skill e.g., word processing, spreadsheet, database, Internet search and utilization.
- Flexible and able to work in a fast-paced environment.
- English read/write fluency a MUST. A second global language is a plus.
- Team player with excellent organizational and interpersonal skills.
- Ability to organize and judge priorities.
- Excellent ability to generate and maintain accurate records
