Regulatory Associate

Marmon Holdings, Inc.•Hillsboro, OR

About The Position

The Regulatory Associate supports the international regulatory function by helping to maintain regulatory processes and systems. Utilizes computer and software proficiencies to create, coordinate, procure and/or maintain data and documentation to support OUS medical device registration. The Regulatory Associate also employs an attention to detail and developing familiarity with products and processes to ensure databases, dashboards and documents are current and correct. Provides support to other senior members of the department as required.

Requirements

Bachelor’s degree in science, health, or technical discipline. Relevant experience may be considered in lieu of educational background.
0 - 2 years of medical device regulatory experience.
Computer/technical proficiency including experience with MS Office and working knowledge of Adobe, SAP, Windchill and other software as needed.
Ability to work well with others, manage multiple projects simultaneously, and follow directions.
Excellent attention to detail and verbal and written communication skills.
Ability to read and speak English sufficiently to read, understand and complete all documentation.

Nice To Haves

Being a notary or ability to obtain license as notary is preferred.
Knowledge of applicable EU and/or other region-specific medical device regulations, requirements and standards preferred.
Experience with quality and document control systems in a regulated space preferred.

Responsibilities

Enters and maintains registration data in database(s) and dashboard(s).
Audits registration data in applicable systems to ensure data is current and correct.
Provides support for and/or prepares the creation of technical and other documentation for international regulatory submissions (new and renewals) according to applicable standards/regulations.
Provides support for various labeling programs/updates, changes to regulatory-owned documents within document control systems, updates to other documentation (e.g., IFUs), data searches compilation (e.g., for clinical evaluation), and Regulatory review of Change Notices to determine notification to international regulatory agencies.
Supports audits by third parties (FDA, BSI, and Others) as required.
Ensures documents are stored per procedure, including registration submissions and correspondence with regulatory bodies.
Maintains other records, databases, systems as needed in support of regulatory activities (e.g., consensus standards, journal articles, contracts, purchase orders).
Provides administrative regulatory support as needed such as consolidation of multiple documents into a single document, bookmarking relevant sections, preparation for e-submission, etc.
Coordinates signature of various documents for international submission.
Conducts various administrative duties for the International RA team including POs, meeting coordination, etc.
All other duties as assigned.