Job Location : Victor,NY, USA
*ALL APPLICATIONS MUST INCLUDE COVER LETTER AND RESUME TO BE CONSIDERED*
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 I, II
SALARY RANGE: $85,000 - $104,000
POSITION HOURS: 8:00AM - 5:00PM
POSITION LOCATION: Onsite at LSI Solutions in Victor, NY
POSITION AT-A-GLANCE: Primary responsibilities of the clinically-focused Regulatory Associate will be collecting and collating relevant clinical data pertaining to LSI's medical device products from multiple sources, such as: engineering, risk management, post-market surveillance, and other in-house teams, as well as clinical publications resulting from active literature searches and analysis. The Regulatory Associate will organize and use this comprehensive data to write clinical evaluation reports (CERs) and proposals for new medical devices, or update reports for existing devices. Cross-training with other functions of the regulatory team includes activity in post-market surveillance as well as supporting clinical studies of subject devices by partner investigators. Desired traits include good writing, attention to detail, well-organized & decent planning skills, interest in identifying and reviewing relevant clinical literature, and an ability to work independently developing written deliverables with defined deadlines.
Locally owned Victor, NY-based LSI Solutions Inc ( . (est. 1986) is a +500-employee developer and manufacturer of surgical devices, with over a dozen product families in US and global markets and others in late-stage development, with products benefiting surgical patients in over 80 countries. Members of the clinically-focused regulatory team are directly involved in data evaluation and the demonstration of safety and effectiveness of LSI products, and exposed to a variety of disciplines of the biomedical device industry, including engineering (device development, quality, and other fields), risk management, R&D, post-market vigilance, biocompatibility, labelling, and domestic and international regulatory affairs.
JOB SUMMARY: The Regulatory Associate applies her/his experience, knowledge, organization skills, and communication skills in a wide variety of tasks. 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. They 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 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:
Regulatory Associates I and II:
+ Understand and maintain LSI file structures and locations for controlled documents.
+ Complete all assigned quality management system training on schedule.
+ Prepare attachments and hyperlinks for submissions to regulatory agencies, notified bodies, competent authorities, and/or authorized representatives.
+ Provide audit support. 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.
+ Understand the commercial release authorization process.
+ Process complaint intake as a backup to the complaint coordinator as needed.
+ Perform all other responsibilities as assigned.
Additionally, Regulatory Associates II:
+ 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.
Regulatory Associates focused on Clinical Evaluation:
+ Contribute to clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market clinical follow-up (PMCF) plans.
+ Conduct literature searches in support of clinical evaluations.
+ Apply scientific principles in the understanding of the safety and efficacy of LSI products.
EDUCATION & EXPERIENCE:
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.
+ Able to gain basic understanding of FDA Quality System Regulation and ISO 13485.
+ Proficient with various computer programs, including MS Office.
+ Proficient with customer relationship management.
+ Love of Learning and Positive Attitude.
+ Trustworthy.
+ Some travel may be required (