B.S. degree in life science or technical discipline (engineering, bioengineering, biology, chemistry preferred)
2-5 years of experience in the Medical Device sector
At least 2 years of experience in Regulatory Affairs for Medical Devices
Familiarity with FDA guidance and industry consensus standards
Proven track record with FDA and EU Notified Bodies
Regulatory Affairs Certification (RAC) from RAPS
Proficient in Microsoft Office and project management.
Responsibilities
Prepare regulatory submissions for U.S. and European medical device marketing.
Provide regulatory guidance on project teams throughout the product lifecycle.
Support international product registrations, including new registrations and re-registrations.
Collect registration information from departments like R&D, Quality, and Manufacturing.
Determine submission necessity for 510(k) applications and prepare justifications for non-filing.
Prepare/update technical files for CE marking with input from multiple functions.
Submit notifications to EU Notified Body for significant changes to CE marked products.
Benefits
Opportunity to work on cross-functional project teams
Exposure to diverse regulatory environments in both U.S. and Europe
Engagement in significant regulatory milestones for innovative medical devices
Possibility of involvement in special projects that enhance professional growth
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.
