JOB SUMMARY: The European Regulatory Specialist applies her/his experience, knowledge, organization skills, and communication skills to 1) prepare regulatory submissions, including CE mark applications, for one or more European Notified Bodies as required to market LSI’s new or modified medical devices in Europe, including all relevant maintenance activities; 2) monitor and communicate status of regulatory submissions and perform duties related to regulatory post-market surveillance, and vigilance reporting; 3) provide regulatory feedback and guidance to the company throughout the development cycle; 4) Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions.
REPORTS TO: European Regulatory Manager
Participate on product development teams by providing assessment of new devices, proposed changes or enhancements to existing devices, regulatory strategy, timelines, and deliverables ensuring proper European governing requirements are incorporated as part of the development process for products targeted for Europe to ensure timely regulatory submissions and approval.
Maintain full Quality and Regulatory compliance with all standards that govern the design, development, manufacture, and distribution of LSI’s medical devices.
Provide regulatory feedback and guidance to the company throughout the development cycle.
Independently author, prepare, and compile regulatory documents for product submissions to one or more European Notified Bodies; Collaborate with appropriate departments to ensure applicable materials are developed to enable European product market clearance, approval and continuance during product life cycle; Assemble materials and data required for timely completion of European regulatory submissions: MDD/MDR, CE dossiers.
Coordinate with other Regulatory members as needed to ensure reporting requirements regarding new and modified device requirements under other international standards/rules are met.
Maintain appropriate European registrations and product listings.
Apply scientific principles to understanding safety and efficacy of our products.
Ensure product labeling meets requirements.
Monitor the global regulatory developments of new regulations, standards, policies, and guidance issued by regulatory authorities that may have impact to LSI and interpret existing or revised requirements via the Quality Management System and/or training as they relate to the company products and procedures.
Provide assistance as needed with corporate regulatory compliance, including regulatory audits.
Interface, communicate, and coordinate with one or more European Notified Bodies under the supervision of Executive Leadership.
Attend labs where technology under development is being tested to gain more understanding of how the technology is used.
Provide guidance in regards to the regulatory aspects of product design and development to include preliminary regulatory assessments, regulatory strategy, product labeling, indications for use, contraindications, etc.
Review relevant documents in the document management system.
Perform all other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
Excellent communication skills (verbal and written).
Excellent attention to detail and strong follow-up skills.
Proficient with European regulatory requirements (MDD/MDR 2017/745) and submissions affecting medical device manufacture and sale.
Experienced in successfully working with one or more European Notified Bodies.
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 MSExcel).
Proficient in project planning and tracking.
Effective time management.
Customer-focused, goal-oriented self-starter.
Basic understanding of FDA Good Management Practices (GMPs), Good Clinical Practices, FDA’s Quality System Regulation, and applicable regulations and industry standards regarding clinical research and regulation of medical devices.
Knowledge of international regulatory requirements affecting medical device manufacture.
Knowledge of domestic MDR and international vigilance reporting requirements for medical devices.
Love of Learning and Positive Attitude.
Ability to multi-task and manage time.
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.
EDUCATION & EXPERIENCE:
Bachelor or Master’s degree, preferably in Life Sciences or Engineering disciplines, with at least 3 years’ Regulatory experience (medical devices preferred).
Experienced with successfully preparing and submitting CE mark applications with a Notified Body which have resulted in timely CE marking, preferably for medical devices.
Regulatory Affairs Certification (RAC) a plus, but not required.
LSI SOLUTIONS® is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic.
LSI SOLUTIONS®, located in beautiful Victor, New York, is a dynamic and growing medical device company dedicated to advancing minimally invasive therapeutics through research, development, manufacturing, and marketing of minimally invasive surgical instruments.