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

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Regulatory Affairs Operations Specialist

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