Regulatory Affairs Specialist II

Overview

Regulatory Affairs Specialist II role at Katalyst CRO
. This position focuses on regulatory submissions for medical devices in the U.S. and Europe, support of international product registrations and related regulatory activities, and ensuring that the product development process addresses regulatory requirements and business objectives. It requires data analysis, problem solving, and attention to detail.

• Prepare regulatory submissions to market medical devices in the U.S. and Europe; support international product registrations and related regulatory activities; ensure product development addresses regulatory requirements and business objectives; requires data analysis, problem solving, and attention to detail.
• Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate inputs for regulatory submissions, and review and approve applicable design control documentation.
• Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications.
• Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc.
• Assess necessity for submitting a 510(k) application for proposed device changes; prepare internal "Non-Filing Justifications (U.S.)" for changes that do not require a 510(k) submission.
• Prepare/update technical files for CE marking with input from various functions (R&D, Quality, Medical, Manufacturing, etc.).
• Submit notifications to the EU Notified Body for significant changes to CE marked products.
• Maintain Regulatory documentation.
• Support special projects, as needed.

• B.S. degree or higher in a life science or technical discipline (engineering, bioengineering, biology, or chemistry).
• 2-5 years of Medical Device experience.
• Working knowledge of industry consensus standards and FDA guidance.
• At least 2 years' Regulatory Affairs experience in Medical Device regulations.
• Demonstrated success in taking products through FDA and EU Notified Bodies.
• Working knowledge of 510(k), MDD 93/42/EEC.
• RAC (RAPS) certification.
• Proficient in Microsoft Office; strong communication and project management skills; ability to handle multiple tasks; attention to detail.
• 510(k), MDR knowledge; 21 CFR 820; ISO 13485; familiarity with medical device standards and FDA guidance.

• Seniority level:
  Associate
• Employment type:
  
  Contract
• Job function:
  Legal
• Industries:
  Pharmaceutical Manufacturing