Regulatory Associate I / Regulatory Affairs - Days 8am to 5pm

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LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000 sq ft) on 95 meticulously cared for acres.

We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our ultimate customer is the patient.

POSITION TITLE: Regulatory Associate - Days 8am to 5pm

SALARY RANGE: $85,000 - $95,000

JOB SUMMARY: The Regulatory Associate applies her/his experience, knowledge, organization skills, and communication skills in a wide variety of tasks. All Regulatory Associates provide regulatory feedback and guidance based on medical device regulations and standards to the company throughout the development cycle. Regulatory Associates monitor regulations, standards, policies, and guidance for new and current compliance requirements that may have impact to the company. Regulatory Associates maintain technical documentation and help to implement change control at LSI. Regulatory Associates are assigned to work in one or more of the following areas: Domestic, European, Rest of World, Labeling, and/or Clinical & Post Market Surveillance. Regulatory Associates assigned to Domestic projects will contribute to regulatory strategies for design and development projects and contribute to regulatory submissions to the FDA when appropriate. Regulatory Associates assigned to European regulatory projects will be involved with medical device classification, preparation of technical documentation, conformity assessments, and notices of change in compliance with the EU MDR and associated guidance. Regulatory Associates assigned to Rest of World projects will work with distributors to provide documents for regulatory submissions required to market LSI’s new or modified medical devices in many countries outside the U.S and Europe. Regulatory Associates assigned to Labeling projects apply knowledge of U.S. and international regulations and standards with highly cross-functional teams to ensure compliance for IFU, UDI, and promotional material requirements. Regulatory Associates assigned to Clinical projects contribute to clinical evaluation, investigator brochures, post-market clinical follow-up, and post market surveillance. All Regulatory Associates will also maintain full Quality and Regulatory compliance with all standards that govern the design, development, manufacturing, and distribution of our medical devices.

Essential Functions

The Regulatory Associate role has three levels: I

All Regulatory Associates I

• Understand and maintain LSI file structures and locations for controlled documents and the Regulatory drive.
• Complete all assigned quality management system training on schedule.
• Prepare attachments and hyperlinks for submissions to regulatory agencies, notified body, competent authorities, and/or authorized representative.
• Provide audit support in the audit backroom.
• Support internal and external audits and compliance assessments.
• Provide regulatory feedback and guidance based on medical device regulations and standards to the company throughout the development cycle.
• Attend labs where technology under development is being tested to gain more understanding of how the technology is being used.
• Locate all regulatory certificates.
• Independently generate document change requests as needed.
• Understand the commercial release authorization process and update commercial release authorizations as directed.
• Process complaint intake as a backup to the complaint coordinator as needed.
• Perform all other responsibilities as assigned.
  
  

Furthermore, Regulatory Associates will be assigned to work in one or more of the following areas, each of which areas has essential functions which vary by Regulatory Associate level as noted. Regulatory Associates only need to complete the essential functions in one of the following areas in addition to the above generally applicable essential functions to attain their level (I, II, or III), provided management has assessed the employee has suitable performance and time being responsible for such functions.

• Domestic
  
  

All Regulatory Associates I, II, And III – Domestic Area

• Accurately classify medical devices per U.S. regulations and clearly document associated rationale.
• Update and maintain accuracy of LSI device listings and registrations with the FDA.
• Prepare accurate 510(k) acceptance checklists, medical device user fee sheets, and CDRH presubmission review cover sheets.
• Rest of World
  
  

All Regulatory Associates I, II, and III – Rest of World Area:

• Update and maintain accuracy of LSI’s international device listings and registrations.
• Prepare registration application materials through approval for ROW countries/regions not including Europe, UK, China, Japan, Russia, Korea, Australia, and Canada).
• Work with distributors to provide requested documents.
• Maintain the controlled list of international approved countries in full compliance to support product distribution and sales.
• European
  
  

All Regulatory Associates I, II, And III – European Area

• Accurately classify medical devices per EU regulations and clearly document associated rationale.
• Identify appropriate EU conformity assessment pathways and clearly document associated rationale.
• Contribute to update of existing technical documentation.
• Update and maintain accuracy of LSI’s European device listings and registrations.
• Contribute to creation of technical documentation for new conformity assessments.
• Labeling
  
  

All Regulatory Associates I, II, And III – Labeling Area

• Accurately complete regulatory labeling checklist reviews for labeling content associated with LSI’s medical devices.
• Understand, know, and have thorough command of LSI’s Instructions for Use (IFU) portfolio.
• Understand, know, and have thorough command of LSI’s marketing material portfolio.
• Understand, know, and have thorough command of LSI’s website content.
• Clinical & Post Market Surveillance
  
  

All Regulatory Associates I, II, III – Clinical & Post Market Surveillance Area:

• Contribute to clinical evaluation plans (CEPs) and post-market clinical follow-up (PMCF) plans.
• Conduct literature searches in support of clinical evaluations.
• Contribute to Periodic Safety Update Reports (PSUR).
• Contribute to Post Market Surveillance (PMS) reports.
  
  

Education & Experience

Regulatory Associate I:

• Bachelor or Master’s degree in a technical, regulatory, or life sciences discipline with 0-2 years’ experience in FDA regulated environment (medical devices preferred).
  
  

Knowledge, Skills & Abilities

• Effectively manage time and resources.
• Excellent verbal and written communication skills.
• Team oriented worker.
• Customer-focused, goal-oriented self-starter.
• Requires strong attention to detail and excellent follow-up skills.
• Basic understanding of FDA Quality System Regulation.
• Basic understanding of ISO 13485.
• If assigned to the European Regulatory Team, a basic understanding of European Medical Device Regulation.
• If assigned to the Rest of World Regulatory Team, a basic understanding of international regulatory fundamentals for medical devices.
• If assigned to the Labeling Regulatory Team, a basic understanding of U.S. and European Labeling regulations and standards for medical devices.
• If assigned to the Clinical & PMS Regulatory Team, a basic understanding of ISO 14155 and European MDR Article VII and Annex XIV.
• Proficient with various computer programs including MS Office.
• Proficient with customer relationship management.
• Love of Learning and Positive Attitude.