Manufacturing & Distribution, Medical Device, Quality/Risk Management, Submission & Registration
4 Year Degree
JOB SUMMARY: The Regulatory Specialist is responsible for planning, organizing, and implementing 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.
REPORTS TO: Domestic Regulatory Manager
Drives global harmonization of core labeling content review by assessing, approval, and release of product related labeling and marketing materials (i.e. IFU, artworks, leaflets, brochures).
Participate in product development teams by providing assessment of proposed changes, regulatory strategy, timelines, and deliverables ensuring proper governing (US/EU) requirements are incorporated as part of the development process.
Lead and coordinate product risk management requirements including evaluation of biocompatibility.
Apply scientific principles to understanding safety and efficacy of our products.
Author, prepare, and compile 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.
Monitor the global regulatory developments of new regulations, standards, policies, and guidance issued by regulatory authorities that may have impact to the company and interpret existing or revised requirements via the Quality Management System and/or training as they relate to the company products and procedures.
Interface, communicate, and coordinate with the FDA, Notified Bodies, Competent Authorities, and other regulatory agencies on submissions, approvals, or other issues under the supervision of regulatory management.
Assist in development, writing, and maintaining regulatory departmental procedures and process improvements.
Review and approve product and manufacturing changes to assess regulatory impact while considering US/EU/ROW regulatory requirements.
Prepare and update US product listings and EU/CA/ROW registrations.
Ensure product labeling meets requirements.
Support internal and external audits and compliance assessments.
Perform all other responsibilities as assigned.
Act as secondary contact for receiving, processing, tracking, investigating, and reporting of customer complaints from initiation to closeout. May be required to prepare and submit timely customer response communications to report results of investigation in a professional manner.
Support post market surveillance by providing complaint metrics, trend analyses, and conducting vigilance and MDR reporting to regulatory authorities as required.
Contribute to efficiencies and improvements in the complaint handling process.
Address and advise teams on appropriate pathways to market under the supervision of more experienced regulatory professionals.
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.
Basic understanding of FDA Good Manufacturing Practices (GMPs).
Proficient with Quality Management Systems and their implementation.
Proficient with various computer programs including MS Office.
Proficient with customer relationship management.
Basic knowledge of domestic and international regulatory requirements affecting medical device manufacture.
Basic knowledge of domestic MDR and international vigilance reporting requirements for medical devices.
Development and review of compliant medical device labeling experience preferred.
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 is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic.
EDUCATION & EXPERIENCE:
Bachelor or Master’s degree in technical discipline with experience in FDA regulated environment (medical devices preferred). Regulatory Affairs Certification (RAC) a plus.
Internal Number: 1302
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.