Regulatory Affairs Specialist II

Katalyst CRO; Boulder (CO); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Regulatory Affairs professional to prepare regulatory submissions for U.S. and European markets, support international registrations, and coordinate cross-functional inputs from R&D, Quality, Medical, and Manufacturing.

The role requires RAC certification, 2–5 years in medical devices, and strong knowledge of 510(k) and MDR/MDD, with attention to detail and excellent project management skills.

Qualifications

• BS or higher in life science or technical discipline (engineering, bioengineering, biology, chemistry)
• 2–5 years medical device experience
• FDA guidance and industry standards knowledge
• 2+ years regulatory affairs experience in medical devices (FDA, EU)
• RAC certification (RAPS)
• Proficient in Microsoft Office
• Strong communication and project management
• Ability to manage multiple tasks
• Attention to detail
• Experience with 510(k), MDR/MDD
• Knowledge of 21 CFR 820 and ISO 13485

Responsibilities

• Prepare regulatory submissions for U.S. and Europe to market medical devices.
• Support international product registrations and registrations/notifications.
• Coordinate with R&D, Quality, Medical, Manufacturing for registration information.
• Coordinate and collect registration inputs with cross-functional teams.
• Assess need for 510(k) filings for proposed device changes; prepare internal justifications.
• Prepare/update technical files for CE marking with cross-functional input.
• Submit CE-notifications to Notified Bodies for significant changes.
• Maintain regulatory documentation and support special projects.

Job description

Job Description

• This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail.
• Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team 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 appropriate 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.

Requirements

• B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry
• 2-5 years Medical Device experience
• Working knowledge of industry consensus standards and FDA guidance is required
• 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
• Regulatory Affairs Certified RAC (RAPS)
• Proficient in using Microsoft Office
• Strong communication and project management skills
• Must be able to handle multiple tasks
• Attention to detail
• 510(k), MDR
• 21 CFR 820 - Quality System Regulation, ISO 13485
• Medical device standards and FDA guidance relevant to medical devices.