LSI SOLUTIONS® · 3 months ago
Regulatory Coordinator - Days - 8:00AM to 5:00PM
Victor, NY, US
Full-time
Onsite
Entry, Mid, Senior Level
$25/hr - $28/hr
3+ years expLSI Solutions is a company specializing in medical devices, and they are seeking a Regulatory Coordinator to support their Regulatory Team. The role involves managing administrative tasks related to regulatory compliance, assisting with the procurement of approvals for products, and ensuring adherence to quality standards.
Health CareManufacturingMedical
Responsibilities
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
Locate all regulatory certificates
Independently generate document change requests as needed
Assist in review and compilation of the submission files to obtain market approvals in the USA (510(k), Canada, Europe (MDD/MDR), Australia, and ROW ensuring all US/EU/CA requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices
Revise regulatory procedures with direction
Generate and update complaint metrics
File MedWatch reports with the FDA as directed
File international adverse event reports as directed
Document minutes from the Complaint Liaison Meeting
Track country renewal requirements and deadlines
Maintains the Report of International Approved Countries for Distribution per LSI’s Quality Management System (QMS) procedures
Conduct Gap Assessments
Independently revise regulatory procedures as assigned
Apply knowledge of adverse event reporting to implementing updates to new adverse event reporting requirements
Draft and revise complaint procedures
Participate in external audits as a complaint subject matter expert
Advise engineers doing complaint analysis on the complaint handling process
Update and maintain accuracy of LSI device listings and registrations with the FDA
Independently finds most information requested by distributors
Prepare registration application materials through approval for ROW countries/regions not including Europe, UK, China, Japan, Russia, Korea, Australia, Brazil, and Canada
Qualification
Required
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
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
Preferred
1-2 years of experience working as a Regulatory Coordinator at a medical device company operating within a Quality Management System (QMS) certified to ISO 13485
Familiar with 21 CFR 820, 21 CFR 803, and ISO 13485
2-3 years of experience working as a Regulatory Coordinator at a medical device company operating within a Quality Management System (QMS) certified to ISO 13485, said experience relevant to and demonstrating effective performance related to the Regulatory Coordinator III Essential Functions listed above
Familiar with Canadian, European, Japanese, Australian, and Brazilian adverse event reporting requirements for medical devices
Benefits
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
Company
LSI SOLUTIONS®
We at LSI Solutions integrate patient‑focused values, precision manufacturing, and deep surgical collaboration to redefine what's possible in minimally invasive surgery.
501-1000 employees
H1B Sponsorship
LSI SOLUTIONS® has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2023 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
J
Jude S. Sauer
President & CEO
Recent News
2025-04-02
Company data provided by crunchbase