B.S. or higher in life science or technical discipline (engineering, bioengineering, biology, chemistry preferred)
2-5 years of experience in Medical Device industry
At least 2 years in Regulatory Affairs specific to Medical Device regulations
Familiarity with FDA and EU Notified Body processes
Knowledge of 510(k), MDD 93/42/EEC regulations
Regulatory Affairs Certification (RAC) from RAPS is preferred
Strong proficiency in Microsoft Office and project management skills
Responsibilities
Prepare regulatory submissions for U.S. and Europe to market medical devices
Provide regulatory guidance on project teams during product development cycle
Support and coordinate international product registrations and notifications
Collect registration information from R&D, Quality, Medical, and Manufacturing
Assess and document the need for 510(k) applications for device changes
Prepare and update technical files for CE marking
Submit significant change notifications to EU Notified Body
Maintain regulatory documentation and support special projects as needed
Benefits
Opportunity to work with innovative medical device technologies
Collaborate with cross-functional teams in a dynamic environment
Impactful role with a focus on ensuring regulatory compliance
Potential for professional development and certification opportunities
Engagement with international regulatory frameworks
Full Job Description
Responsibilities:
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.
ssess 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
t 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
ttention to detail
510(k), MDR
21 CFR 820 - Quality System Regulation, ISO 13485
Medical device standards and FDA guidance relevant to medical devices.
