Acumed LLC
Medical Device
RegulatorySpecialist2
Neural analysis suggests this role is
optimal for Mid candidates.
“Regulatory Specialist 2 at Acumed LLC. Skills: Regulatory Compliance, Medical Devices, Regulatory Submissions, FDA. Ensure regulatory compliance for medical devices. Assist in regulatory submissions, listings, and registration”
Industry & Context.
Investigates when clarification is needed; Assists in determination of appropriate safety, regulatory, evaluation and testing requirements; Evaluation of effects of regulatory, design, and manufacturing changes
What They're Looking For.
Must Have
Bachelor’s degree in engineering or science discipline, 3-5 years of regulatory experience in the medical device industry, 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, Ability to work well with others, Excellent written and verbal communication skills, Ability to read and speak English sufficiently to read, understand and complete all documentation, Exceptional organizational skills with extensive knowledge of MS Office i.e., Excel, Word, Outlook
Nice to Have
Knowledge and experience with ERP systems and their applications, SAP preferred
What You'll Do.
Ensure regulatory compliance for medical devices
Assist in regulatory submissions
Maintain working knowledge of medical device regulations
Report regulation and standard changes
Assist in determining safety
evaluation and testing requirements
Conduct documentation reviews and change assessments
and coordinate data for submission
Manage correspondence with regulatory agencies
Support internal and external audits
Assist in development
and application of labeling
Maintain processes and procedures for RA functions
Provide regulatory perspective to cross-functional teams
Review and disposition ECRs/ECOs
Review and approve test protocols and reports
Create and maintain IFUs
Review and approve labeling
Provide feedback on advertisement/promotional material
Prepare Letter to File for design changes
Prepare submissions to regulatory agencies
Provide regulatory training
How You'll Work.
Team & Collaboration
Increasing cross functional interaction both internally and externally; Works with team members to conduct documentation reviews; Provides regulatory perspective to cross-functional teams
Communication Scope
Excellent written and verbal communication skills; Ability to read and speak English sufficiently
Full Job Description
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., subm
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