Manufacturing & Distribution, Medical Device, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
JOB SUMMARY: The Domestic Regulatory Manager applies her/his experience, knowledge, organization skills, and communication skills to 1) prepare regulatory submissions, including 510(k) applications, required to market LSI’s new or modified medical devices in the United States, 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) Prepare and file requests for feedback on medical device submissions with the FDA pre-submission program, and attend pre-submission meetings with the FDA, as required; 5) Prepare regulatory non-filing justifications, as required; 6) Provide expert level 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.; and 7) Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions.
REPORTS TO:Intellectual Capital Director
Manage and coordinate Domestic Regulatory activities to support company goals, objectives, and product development including direct supervision of Regulatory Affairs Associates and/or Specialists assigned to the Domestic Regulatory Team.
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 governing (US) requirements are incorporated as part of the development process to ensure timely regulatory submissions and approval. Our goal is to be involved with the development process early and often to facilitate and enable FDA clearance in a predictable, fully compliant, and extremely efficient manner.
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 prepare regulatory documents for product submissions. Collaborate with appropriate departments to ensure applicable materials are developed for new product market clearance, approval and continuance during product life cycle; assemble materials and data required for timely completion of domestic regulatory submissions: PMA 510(k), IDE.
Prepare and file requests for feedback on medical device submissions with the FDA pre-submission program, and attend pre-submission meetings with the FDA, as required.
Prepare regulatory non-filing justifications, as required
Coordinate with other Regulatory Teams/members as needed to ensure reporting requirements regarding new and modified device requirements under other international standards/rules are met.
Review new and modified devices for fulfillment of FDA premarket obligations and identification of appropriate standards for medical device safety with knowledge of FDA 510(k) and FDA PMA.
Maintain appropriate domestic registrations and product listings.
Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions.
Monitor the domestic 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 the FDA 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 expert level 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 documents in our Document Management System during the design and development process.
Prepare Clinical Evaluation Reports (CERs) and Implement processes for Post-Market Surveillance (PMS).
Perform all other duties as assigned.
Prepare and conduct objectives & goals reviews for direct reports.
EDUCATION & EXPERIENCE:
Bachelor’s degree required (preferably in Life Sciences or Engineering disciplines) and a Master’s degree preferred with 5 years’ experience in FDA regulated environment (medical devices preferred).
Experienced with successfully preparing and submitting 510(k) applications which have resulted in timely FDA clearance, preferably for medical devices, both directly with the FDA and via an Accredited Person.
Experienced with the FDA pre-submission question process.
Regulatory Affairs Certification (RAC) a plus, but not required.
KNOWLEDGE, SKILLS & ABILITIES:
Excellent communication skills (verbal and written).
Excellent attention to detail.
Proficient with domestic (U.S.) regulatory requirements and submissions affecting medical device manufacture and sale.
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).
Team oriented facilitator/mentor/contributor.
Proven leadership skills.
Customer-focused, goal-oriented self-starter.
Proficient in project planning and management.
General understanding of Good Clinical Practices, FDA’s Quality System Regulation, ISO 13485, MDD, MDR 2017/745 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.
Occasional travel (less than 5% of the time) may be required.
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.
Internal Number: 1324
About LSI Solutions
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.