Regulatory Associate

Acumed LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Job Scope

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.

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. Being a notary or ability to obtain license as notary is preferred.
• Conducts various administrative duties for the International RA team including POs, meeting coordination, etc.
• All other duties as assigned.

Qualifications

• 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.
• 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.
• 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.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [email protected], and please be sure to include the title and the location of the position for which you are applying.