Job Summary

This is a highly visible role and will require extensive interaction with upper management as well as regulatory bodies.

Main Duties:

• Successful Global Regulatory Submissions and Approvals, including 510(k)s and Technical Documentation Review by Notified Body in EU.

• Prepared product registrations for various countries and/or provided additional information to regulatory bodies for successful registration of products.

• Reviewed design and labeling changes to assess regulatory impact, filed various submissions and updates with regulatory agencies.

• Maintained up-to-date regulatory requirements for the business unit (Registrations/Regulatory Audits/Quality Manual/Quality System Certificates).

• Prepared and submitted 510(k)'s, IDEs, and other applicable product submissions according to FDA guidelines.

Job Responsibility:

Regulatory specialist with proven ability in presenting, developing, and implementing pre and post-market regulatory strategies for medical device submissions for US and OUS. Interface with regulatory authorities representing the organization.

Responsible for regulatory review of new supplier &part qualifications. Supported for submissions to EU and FDA. Authored and implemented a Regulatory Compliance Plan for New Product Development.

Lead site readiness efforts prior FDA, TUV/ISO, and vendor audits and war room. Interfaced with auditors for reviews and retrievals. Responded all audit questions and post requests from regulatory agencies. Post-market surveillance report for annual submission. Led development and preparation of SOPs.

Leading reviews and response management for submissions for approvals by working with cross-functional members.

Leading labeling remediation project incorporating FDA/OUS guidance & harmonized standards. This also includes UD

Other Skills:

• Extensive experience as a direct correspondent to negotiate and build relationships with FDA, EU Notified Bodies, Health Canada, marketing, quality, and engineering.

• Working knowledge of FDA regulations and EU Directives is advantageous for preparing successful regulatory submissions and maintaining regulatory compliance throughout the product lifecycle.

• Experience in preparing and submitting regulatory submissions (510K, IDE, PMA, and EU technical file).

• Prepared U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements;

Job Type: Contract