Regulatory Specialist 2

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 Affairs (RA) Specialist is responsible for ensuring regulatory compliance for medical devices in accordance with applicable regulatory requirements (FDA, ISO, CE, etc.). The Regulatory Affairs Specialist will assist in regulatory submissions, listings, and registration of medical devices to comply with applicable regulatory standards dependent on functional RA scope (International, RA, Pre-Market and Strategy RA, Post-Market RA, etc.).

With increasing levels, the Regulatory Affairs Specialist will be expected to provide increasing leadership and mentoring along with more cross functional interaction both internally and externally.

Responsibilities

• Understands regulations, follows complex directions, and investigates when clarification is needed.
• Maintains working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to, registration, classification, labeling, and post-market surveillance requirement through on-going education and training.
• Reports relevant regulation and standard changes and assists in determining impact and appropriate action.  Ensures regulatory compliance of products and processes through participation in process updates.
• Assists in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products.
• Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action e.g., submissions, notifications.
• Prepares, organizes, and coordinates data for submission to and manages correspondence with the regulatory and standards agencies or organizations such as but not limited to FDA, Notified Body, Health Canada, ISO, Acumed’s EU Authorized Representative, ANVISA, PMDA, TGA, and Third-Party License Holders.
• Manages correspondence with regulatory and standards agencies or organizations such as but not limited to FDA, Notified Body, Health Canada, ISO, Acumed’s EU Authorized Representative, ANVISA, PMDA, TGA, and Third-Party License Holders.
• Supports internal and external (third party) audits as required.
• Assists in development, organization, and application of labeling e.g., instructions for use (IFU), package labels, etc. Initiates updates to labeling to ensure compliance with registrations.
• Maintains processes and procedures for essential RA functions.
• Provides regulatory perspective to cross-functional teams e.g., product development and risk management, to ensure products are compliant with relevant US and international medical device standards, codes, and regulations.
• Reviews and disposition ECRs/ECOs for potential impact to new and existing registrations. Converts and/or approves ECRs/ECOs requiring regulatory review.
• Reviews and approves test protocols and test reports necessary to support market registrations.
• Creates and maintains IFUs. Reviews and approves labeling. Provides feedback advertisement/promotional material to ensure regulatory compliance. 
• Prepares and ensures content accuracy for Letter to File (LTF) for design changes.
• Prepares and ensures content accuracy for submission to regulatory agencies e.g., 510(k), PMA, vigilance reports, EU MDR Technical Documentation/Design Dossiers, global registration applications, etc.
• Provides regulatory training to lower-level regulatory personnel.
• All other duties as assigned.

Qualifications

• Bachelor’s degree in engineering or science discipline.
• 3-5 years of regulatory experience in the medical device industry e.g., quality, regulatory, or engineering. Equivalent industry/educational experience may be considered.
• Thorough working knowledge of applicable FDA, ISO, EU MDR requirements, consensus standards and guidance documents.
• Ability to represent and provide regulatory support in audits/inspections, product development, sustaining activities, and other activities as directed.
• Experience in communications and submissions with regulatory authorities including 510(K)s, product registrations, change notifications, field actions/recalls. etc