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 customer is ultimately the patient. JOB TITLE: Regulatory Specialist (Labeling) - Days 8:00AM to 5:00PM SALARY RANGE: $113,000 - $131,000 POSITION HOURS: 8:00AM - 5:00PM LOCATION: Onsite at LSI Solutions in Victor, NY JOB SUMMARY: The Regulatory Specialist applies her/his experience, knowledge, organization skills, and communication skills in a wide variety of tasks. Regulatory Specialists assigned to Domestic Regulatory Projects will 1) prepare regulatory submissions, including FDA Q-Submissions, 513(g) Submissions, 510(k) Submissions, and De Novo Requests as required to market LSI’s new or modified medical devices in the U.S., including all relevant maintenance activities; and 2) provide regulatory feedback and guidance to the company throughout our medical device design and development process. Regulatory Specialists assigned to Global Regulatory Projects will 3) work with distributors to prepare regulatory submissions required to market LSI’s new or modified medical devices outside the U.S. All Regulatory Specialists will also 4) monitor and communicate status of regulatory submissions and perform duties related to regulatory post-market surveillance, and vigilance reporting; 5) read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions; 6) participate in the corrective and preventive action (CAPA) process; and 7) plan, organize, and implement strategies and activities required to procure regulatory approval for new and revised product lines, while maintaining full Quality and Regulatory compliance with all standards that govern the design, development, manufacturing, and distribution of our medical devices. ESSENTIAL FUNCTIONS: The Regulatory Specialist role has four levels: I, II, III, and Senior. All Regulatory Specialists I, II, III, and Senior: Base Level from the prerequisite role (Regulatory Associate) Essential Functions: + 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. + Monitor regulations, standards, policies, and guidance for new and current compliance requirements that may have impact to the company. + Conduct gap assessments. + Maintain full quality and regulatory compliance with all standards that govern the design, development, manufacturing, and distribution of LSI’s medical devices. + Process complaints through our complaint system as a backup to the complaint coordinator as needed. + Search the MAUDE database for adverse events. + Process complaint device return and tracking as a backup to the complaint coordinator as needed. + Lead regulatory training sessions for other teams (inter-team). + Successfully participate in CAPA investigations. + Conduct CAPA verification of effectiveness. + Understand LSI’s BOM structure and can trace related work instructions, process flow diagrams, process control plans, and inspection plans. + File MedWatch adverse event reports as a backup to the complaint coordinator as needed. + File foreign adverse event reports as a backup to the complaint coordinator as needed. + Complete complaint trend reports. + Thoroughly understand the Technical Documentation for LSI’s Knotting, Suturing, and Elegant Elite product lines. + Collaborate with Operations to become familiar with all manufacturing processes used at LSI. + Participate on product development teams by providing assessment of proposed changes, regulatory strategy, timelines, and deliverables ensuring proper governing requirements are incorporated as part of the development process. + Independently complete Change Control Board intake forms. + Complete Change Control Board analysis and risk assessments with mentoring. Additional Essential Functions for all Regulatory Specialists: + Read and interpret regulations for new and current compliance procedures and regulatory enforcement actions/trends. + Review and collaborate on test protocols. + Perform all other responsibilities as assigned. Additionally, All Regulatory Specialists II, III, and Senior: + Lead regulatory knowledge transfer sessions (intra-team). + Review and collaborate on test reports. + Complete internal auditor training and participate on the internal audit team. + Contribute to product risk management (e.g., FMEA and Risk Report Collaboration) Additionally, All Regulatory Specialists III and Senior: + Contribute to supplier quality agreement review and updates. + Contribute to distributor quality agreement review and updates. + Prepare regulatory updates for Management Review. + Lead preparation of Health Risk Assessments. Additionally, All Senior Regulatory Specialists: + Review and approve deviation requests. + Review and approve reworks. + Fill role as an audit host. + Labeling All Regulatory Specialists I, II, III, and Senior – Labeling Area: Base Level from the prerequisite role (Regulatory Associate) Essential Functions: + 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. + Stay up to date on current labeling standards for medical devices. + Stay up to date on current domestic UDI requirements. + Stay up to date on European UDI requirements. + Participate in cross-functional collaboration on labeling changes to existing IFUs, marketing materials, and LSI’s website, including submitting change control forms when appropriate. + Participate in cross-functional collaboration on uFMEAs, implementing learnings from the collaboration to improve IFU precautions, warnings, and clarity of instructions. Additional Essential Functions for all Regulatory Specialists – Labeling Area: + Fulfill role as audit subject-matter-expert (SME) for labeling regulatory topics. + Implement EUDAMED labeling requirements. + Participate in cross-functional collaboration on new Instructions for Use (IFU), including new IFU development, instructions, precautions, warnings, and contraindications. Additionally, All Regulatory Specialists II, III, and Senior – Labeling Area: + Lead creation and revision of Labeling regulatory procedures. + Drive global harmonization of core labeling content. Additionally, All Regulatory Associates III and Senior – Labeling Area: + Independently review Instructions for Use. Additionally, All Senior Regulatory Specialists – Labeling Area: + Review and approve purchase requisitions for labeling content to ensure that labeling orders are up to date. EDUCATION & EXPERIENCE: Regulatory Specialist I: + Bachelor or Master’s degree in a technical, regulatory, or life sciences discipline with 3-5 years’ experience, relevant to the Regulatory Specialist I Essential Functions listed above, in FDA regulated environment (medical devices preferred). Regulatory Specialist II: + Bachelor or Master’s degree in a technical, regulatory, or life sciences discipline with 5-6 years’ experience, relevant to the Regulatory Specialist II Essential Functions listed above, in an FDA regulated environment (medical devices preferred). Regulatory Specialist III: + Bachelor or Master’s degree in a technical, regulatory, or life sciences discipline with 6-7 years’ experience, relevant to the Regulatory Specialist III Essential Functions listed above, in an FDA regulated environment (medical devices preferred). + Regulatory Affairs Certification (RAC) a plus, but not required. Senior Regulatory Specialist: + Bachelor or Master’s degree in a technical, regulatory, or life sciences discipline with 8+ years’ experience, relevant to the Senior Regulatory Specialist Essential Functions listed above, in an FDA regulated environment (medical devices preferred). + Regulatory Affairs Certification (RAC) a plus, but not required. KNOWLEDGE, SKILLS & ABILITIES: + Effectively manage time and resources. + Excellent verbal and written communication skills. + Team oriented worker. + Customer-focused, goal-oriented self-starter. + Excellent attention to detail and strong follow-up skills. + Knowledgeable on FDA Quality System Regulation and proficient with related submissions for device clearance from the FDA. + Knowledgeable on ISO 13485. + If assigned to the European Regulatory Team, knowledgeable on European Medical Device Regulation and proficient with technical documentation and related submissions to a notified body. + If assigned to the Rest of World Regulatory Team, knowledgeable on international regulatory fundamentals for medical devices and proficient with technical documentation and related submissions to authorized representative or competent authority. + If assigned to the Labeling Regulatory Team, knowledgeable on U.S. and European Labeling regulations and standards for medical devices and proficient with labeling sections from submissions to the FDA, notified body, or other competent authority. + If assigned to the Clinical & PMS Regulatory Team, knowledgeable on ISO 14155 and European MDR Article VII and Annex XIV and proficient with post-market requirements. + If assigned to the Domestic Regulatory Team, experienced in successfully working in a regulatory capacity within a medical device design and development project. + Flexibility and dedication to work towards time-sensitive deadlines. + Adept with Microsoft Windows and MS-Office 2010/2013 (specifically with MS-Word, MS-Outlook, and MS-Excel). + Proficient in project planning and tracking. + Knowledge of domestic and international vigilance reporting requirements for medical devices. + Love of Learning and Positive Attitude. + Trustworthy. + Proficient with Quality Management Systems and their implementation. + Some travel may be required but is not anticipated. 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: + Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts + Paid Designated 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.