B.S. degree or higher in life science or technical discipline (engineering, bioengineering, biology, or chemistry preferred)
2-5 years of experience in the Medical Device industry
At least 2 years of Regulatory Affairs experience specific to Medical Device regulations
Demonstrated success in guiding products through FDA and EU Notified Bodies
Knowledgeable about 510(k) submissions and MDD 93/42/EEC standards
Regulatory Affairs Certified (RAC) by RAPS
Proficient in Microsoft Office applications.
Responsibilities
Prepare regulatory submissions for medical devices in the U.S. and Europe
Provide regulatory guidance on project teams throughout product development
Coordinate inputs for regulatory submissions and review design control documentation
Support international product registrations and manage updates/notifications
Assess and document necessity for 510(k) applications for product changes
Prepare and update technical files for CE marking with cross-functional inputs
Maintain comprehensive regulatory documentation.
Benefits
Opportunity to work on pivotal regulatory submissions that impact product marketability
Engagement in international product registrations offering global exposure
Collaboration with multiple departments (R&D, Quality, Manufacturing) to enhance product development process
Potential to support special projects, showcasing adaptability and influence in the company.
Growth potential within a forward-thinking medical device environment.
Full 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.
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.
