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 Coordinator

HOURLY PAY RANGE: $25.00 - $30.00

POSITION HOURS: 8:00AM - 5:00PM

POSITION LOCATION: Onsite at LSI Solutions in Victor, NY

REGULATORY COORDINATOR JOB SUMMARY:

Regulatory Coordinators at LSI Solutions may be assigned various responsibilities for supporting activities on the Regulatory Team, including administration of LSI’s complaint handling system, and assisting with the procurement of domestic and international regulatory approval for new and revised product lines, helping to gather regulatory intelligence regarding updates to U.S. and international medical device regulations, and supporting Rest-of-World (ROW) regulatory approvals, while maintaining full Quality and Regulatory compliance with all standards that govern the design, development, manufacturing, and distribution of our medical devices.

The primary focus will be on Complaint Handling. Specifically, this person will professionally, efficiently, and accurately facilitate complaint intake, initiate device return, track device evaluation, coordinate complaint investigation review, evaluate complaint reportability, and ensure we provide timely, accurate, and consistent responses to complaints received from external customers with respect to our medical devices, while maintaining compliance with applicable U.S. and international medical device regulations, standards, and guidelines for medical devices.

REPORTS TO: REGULATORY COORDINATOR ESSENTIAL FUNCTIONS:

Level I

• Understand and maintain LSI file structures and locations for controlled documents and the Regulatory Drive.

• Obtain apostilling on necessary regulatory documentation.

• Prepare attachments and hyperlinks for submissions to regulatory agencies, notified body, competent authorities, and/or authorized representative.

• Complete all assigned quality management system training on schedule.

• Perform regulatory intelligence monitoring on a regular basis, documenting and distributing results as directed.

• Understand the commercial release authorization process and update commercial release authorizations as directed.

• Support internal and external audits and compliance assessments.

• Act as coordinator for receiving, processing, tracking, investigating, and reporting of customer complaints from initiation to closeout.

• Prepare and send complaint response letters as directed. Prepare and submit timely customer response communications to report results of investigations in a professional manner.

• Search the MAUDE database for adverse events.

• Process complaint device return and tracking.

• Gathers registration materials as requested by distributors, with direction.

• Communicates with distributors for ROW medical device registration, with direction.

• Maintains the ROW Regulatory docket.

• Complete labeling review checklists.

• Keep up to date with the global regulatory developments of new regulations, standards, policies, and guidance’s issued by regulatory authorities that may have impact to the company.

• Perform all other responsibilities as assigned.

  REGULATORY COORDINATOR EDUCATION & EXPERIENCE:

  Level I

• Bachelor’s Degree or 5-10 years of administrative experience with 3+ years of experience handling medical complaints and/or medical records.

• A rudimentary understanding of Regulatory principles that govern medical device companies.

  REGULATORY COORDINATOR KNOWLEDGE, SKILLS & ABILITIES:

• Effectively manage time and resources.

• Excellent verbal and written communication skills.

• Team oriented worker.

• Experienced with database usage and data entry.

• Demonstrated writing ability.

• Experienced with composing correspondence.

• Customer-focused, goal-oriented self-starter.

• Requires strong attention to detail, accuracy, and excellent follow-up skills.

• Troubleshooting and/or problem-solving skills and/or complaint resolution experience.

• Demonstrated ability to maintain confidentiality.

• Experienced with preparing and drafting reports.

• Proficient with various computer programs including MS Office.

• Proficient with customer relationship management.

  REGULATORY COORDINATOR PHYSICAL DEMANDS AND WORK ENVIRONMENT:

  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Sitting, standing, and/or walking for up to eight hours per day.

• Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

  LSI SOLUTIONS BENEFITS INCLUDE:

• Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts

• 15 Paid Holidays, PTO, Sick Time

• Medical, Vision and Dental effective first day of employment

  LSI SOLUTIONS® is an equal opportunity employer and does not discriminate based on any legally protected status or characteristic.

  Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.