Regulatory Affairs Specialist II

Regulatory Affairs Specialist

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.

21 CFR 820 - Quality System Regulation, ISO 13485.

Medical device standards and FDA guidance relevant to medical devices.