Regulatory Affairs Specialist 2

4 weeks ago

Addison, United States Marmon Holdings, Inc. Full time

Acumed LLC

Come join a team where People make the difference As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.

Job Scope

The Regulatory Specialist 2 creates, develops and maintains materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. Works independently as necessary.

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 FDA, EU Notified Body, Health Canada, EU Authorized Representative, and Third-Party License Holders.
  • Manages correspondence with regulatory and standards agencies or organizations such as FDA, Notified Body, Health Canada, ISO, Acumed's EU Authorized Representative.
  • 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 submission to regulatory agencies e.g., 510(k), PMA, vigilance reports, MDR Technical Files/Design Dossiers, global registration applications, etc.
  • Provides regulatory training to lower-level regulatory personnel.
Qualifications
  • Bachelor of Science in biology, chemistry, engineering, or similar degree with 2-5 years of regulatory experience or 6-8 years' 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, 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.
  • Knowledge and experience with ERP systems and their applications, SAP preferred.


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 careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.

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