B.S. or higher in life science or technical discipline (engineering, bioengineering, biology, or chemistry)
2-5 years of experience in the Medical Device sector
At least 2 years in Regulatory Affairs specific to Medical Device regulations
Proven success in navigating FDA and EU Notified Bodies
Familiarity with 510(k) and MDD 93/42/EEC regulations
Regulatory Affairs Certification (RAC) from RAPS preferred
Strong project management and communication skills.
Responsibilities
Prepare regulatory submissions for medical devices in the U.S. and Europe
Provide regulatory guidance and coordinate inputs on project teams
Support all aspects of international product registrations
Collect and coordinate registration information from various departments
Assess and justify the need for 510(k) applications for device changes
Update technical files for CE marking compliance
Notify EU Notified Bodies of significant changes to products
Maintain regulatory documentation for compliance and audits
Assist with special projects as required.
Benefits
Opportunity to work with a diverse and innovative product range
Collaborative work environment with cross-functional teams
Exposure to international regulatory affairs
Professional development opportunities
Contributions that directly impact product safety and efficacy in the market.
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.
