Under direct supervision, prepare moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), CE-Mark Technical Dossier, UKCA Mark, other regional Regulatory submissions, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government

Track multiple projects concurrently

Ensure that existing approvals and documentation are maintained

Communicate with in-country RA personnel to facilitate global clearance/approvals

Monitor, research, and obtain information on FDA clearances/approvals of competitors, and proactively share this information with interested parties

Communicate with regulatory agencies under direct supervision

Perform reviews with some oversight of design control documents (e.g., engineering protocols, reports, product drawings, etc.), quality system procedures relating to commercialization, labeling (e.g., Instructions for Use, product labels, promotional materials), and risk management to ensure regulatory compliance.

Assist in performing moderately complex research to support strategic planning

Analyze existing systems and procedures, recommend solutions/improvements, and write or revise Work Instructions and SOPs as needed to support departmental functions and the Quality System

Understand the Quality System, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, ISO 13485, labeling requirements, Quality System Regulation, Canadian regulations, export requirements, and regulatory requirements of pertinent regions

Assist in activities (e.g., execution, documentation) related to Field Corrective Actions.

What You Contribute

Regulatory Affairs Specialist II

Responsibilities

Qualification

Required

Preferred

Benefits

Company

Penumbrainc

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