LSI Solutions

Maintains the ROW Regulatory docket.. 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.. Maintains the Report of International Approved Countries for Distribution per LSI’s Quality Management System (QMS) procedures.. Also familiar with Canadian, European, Japanese, Australian, and Brazilian adverse event reporting requirements for medical devices.. Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts

regulatory coordinator

<ul><li>ALL APPLICATIONS MUST INCLUDE COVER LETTER AND RESUME TO BE CONSIDERED* </li></ul>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: $24.00 - $38.00 POSITION HOURS: 8:00AM - 5:00PM POSITION LOCATION: Onsite at LSI Solutions in Victor, NY Regulatory Coordinator Job Summary The Regulatory Coordinator is responsible for supporting various 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. REPORTS TO: REGULATORY COORDINATOR ESSENTIAL FUNCTIONS: Level I <ul><li>Understand and maintain LSI file structures and locations for controlled documents and the Regulatory Drive.</li><li>Obtain apostilling on necessary regulatory documentation.</li><li>Prepare attachments and hyperlinks for submissions to regulatory agencies, notified body, competent authorities, and/or authorized representative.</li><li>Complete all assigned quality management system training on schedule.</li><li>Perform regulatory intelligence monitoring on a regular basis, documenting and distributing results as directed. </li><li>Understand the commercial release authorization process and update commercial release authorizations as directed.</li><li>Support internal and external audits and compliance assessments. </li><li>Act as coordinator for receiving, processing, tracking, investigating, and reporting of customer complaints from initiation to closeout. </li><li>Prepare and send complaint response letters as directed. Prepare and submit timely customer response communications to report results of investigations in a professional manner.</li><li>Search the MAUDE database for adverse events.</li><li>Process complaint device return and tracking.</li><li>Gathers registration materials as requested by distributors, with direction.</li><li>Communicates with distributors for ROW medical device registration, with direction. </li><li>Maintains the ROW Regulatory docket.</li><li>Complete labeling review checklists.</li><li>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. </li><li>Perform all other responsibilities as assigned. </li></ul> Level II <ul><li>All essential functions listed above.</li><li>Locate all regulatory certificates.</li><li>Independently generate document change requests as needed.</li><li>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. </li><li>Revise regulatory procedures with direction.</li><li>Generate and update complaint metrics.</li><li>File MedWatch reports with the FDA as directed.</li><li>File international adverse event reports as directed.</li><li>Document minutes from the Complaint Liaison Meeting.</li><li>Track country renewal requirements and deadlines.</li><li>Maintains the Report of International Approved Countries for Distribution per LSI’s Quality Management System (QMS) procedures. </li></ul> Level III <ul><li>All essential functions listed above.</li><li> Conduct Gap Assessments. </li><li> Independently revise regulatory procedures as assigned. </li><li> Apply knowledge of adverse event reporting to implementing updates to new adverse event reporting requirements. </li><li> Draft and revise complaint procedures. </li><li> Participate in external audits as a complaint subject matter expert. </li><li> Advise engineers doing complaint analysis on the complaint handling process. </li><li>Update and maintain accuracy of LSI device listings and registrations with the FDA.</li><li> Independently finds most information requested by distributors. </li><li>Prepare registration application materials through approval for ROW countries/regions not including Europe, UK, China, Japan, Russia, Korea, Australia, Brazil, and Canada. </li></ul> Regulatory Coordinator Team Lead <ul><li>All essential functions listed above.</li><li> Trains Regulatory Coordinators. </li><li> Identifies internal customers of the Regulatory Coordinator Team and interfaces with these customers as needed to understand their requirements and timelines for necessary deliverables. </li><li> Coordinates schedules and project delivery for the Regulatory Coordinators to ensure all associated timelines and deliverables are met. </li><li> Organize the Complaint Liaison Meeting. </li><li> Drive efficiencies and improvements in the complaint handling process. </li></ul>Regulatory Coordinator Education & Experience Level I <ul><li>Bachelor’s Degree or 5-10 years of administrative experience with 3+ years of experience handling medical complaints and/or medical records.</li><li>A rudimentary understanding of Regulatory principles that govern medical device companies. </li></ul>Level II <ul><li>Bachelor’s Degree or 5-10 years of administrative experience with 3+ years of experience handling medical complaints and/or medical records.</li><li>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.</li><li>Familiar with 21 CFR 820, 21 CFR 803, and ISO 13485. </li></ul>Level III <ul><li>Bachelor’s Degree or 5-10 years of administrative experience with 3+ years of experience handling medical complaints and/or medical records.</li><li>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.</li><li>Familiar with 21 CFR 820, 21 CFR 803, and ISO 13485. Also familiar with Canadian, European, Japanese, Australian, and Brazilian adverse event reporting requirements for medical devices. </li></ul>Regulatory Coordinator Team Lead <ul><li>Bachelor’s Degree or 5-10 years of administrative experience with 3+ years of experience handling medical complaints and/or medical records.</li><li>3-4 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 Team Lead Essential Functions listed above.</li><li>Familiar with 21 CFR 820, 21 CFR 803, and ISO 13485. Also familiar with Canadian, European, Japanese, Australian, and Brazilian adverse event reporting requirements for medical devices.</li><li>Previous leadership experience is a plus. </li></ul>Regulatory Coordinator Knowledge, Skills & Abilities <ul><li>Effectively manage time and resources.</li><li>Excellent verbal and written communication skills.</li><li>Team oriented worker.</li><li>Experienced with database usage and data entry.</li><li>Demonstrated writing ability.</li><li>Experienced with composing correspondence.</li><li>Customer-focused, goal-oriented self-starter.</li><li>Requires strong attention to detail, accuracy, and excellent follow-up skills.</li><li>Troubleshooting and/or problem-solving skills and/or complaint resolution experience.</li><li>Demonstrated ability to maintain confidentiality.</li><li>Experienced with preparing and drafting reports.</li><li>Proficient with various computer programs including MS Office.</li><li>Proficient with customer relationship management. </li></ul>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. <ul><li>Sitting, standing, and/or walking for up to eight hours per day.</li><li>Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. </li></ul>Lsi Solutions Benefits Include <ul><li>Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts</li><li>15 Paid Holidays, PTO, Sick Time</li><li>Medical, Vision and Dental effective first day of employment </li></ul>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.

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