Regulatory Affairs Specialist

5 days ago

Columbus, Ohio, United States MILLENNIUMSOFT Full time
Job Title: Regulatory Affairs Specialist

Location: Remote

Contract Term: 5+ Months

Weekly 40.00 Hours [Mon - Fri]

Description:

This position is responsible for supporting regulatory submissions required to market medical devices in the U.S., Europe, and other international markets. The successful candidate will analyze data, solve problems, and evaluate various factors to ensure regulatory compliance.

Responsibilities:
  1. Assess the necessity for submitting a 510(k) application for proposed device changes and prepare internal justifications for changes that do not require a 510(k) submission.
  2. Support preparations for technical files for CE marking with input from various functions in a timely manner.
  3. Notify the Notified Body about significant changes to CE marked products in a timely manner.
  4. Review and approve labeling, promotional, and advertising materials to ensure regulatory compliance.
  5. Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.
  6. Coordinate and collect registration information with R&D, Manufacturing, QA, Medical, and other applicable departments as necessary.
  7. Support international registrations related to product changes and/or new product launches.
  8. Write and update standard operating procedures, work instructions, and policies as needed.
  9. Create and maintain regulatory performance metrics.
  10. Identify opportunities to improve existing processes and implement improvements.
  11. Work with the Regulatory Project Manager to execute large-scale projects, such as EU MDR.
Requirements:

B.S. degree or higher in a life science or technical discipline, preferably in biology, chemistry, engineering, bioengineering, or regulatory affairs.

RAPS Certification is a plus.

5-7 years of regulatory affairs experience in medical device regulations.

Understanding of US, EU, and international medical device regulatory requirements.

Proficient in using various computer programs.

Strong oral and written communication skills.

Project management skills.

Ability to handle multiple tasks and prioritize effectively.

Attention to detail.

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