The Regulatory Affairs Specialist (RAS) will assume responsibility for the independent preparation and submission of international product registrations for Rest of World (ROW) countries, including Canada.
Additionally, the Regulatory Affairs Specialist is responsible for planning and executing global regulatory strategies necessary to obtain and maintain regulatory approvals for new and modified medical devices in International and US regions. The RAS translates regulatory requirements into project/product requirements and will assist in the preparation of regulatory submissions and negotiates their approval with regulatory agencies as required.
Primary responsibilities include; preparing, ROW documentation required for licensing of New World Medical product; assist in the preparation of Technical Files, providing documentation for international submissions; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.
Plans and prepares regulatory submission documents for US and OUS regulatory filings under minimal supervision.
Prepares documentation that is complete, accurate, and on time.
Utilizing detailed, in-depth understanding of regulations, interprets regulations, and provides regulatory guidance to product development teams.
Assist in the development of RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
Participates in audits and inspections of the company and its quality systems.
Team with business unit to provide regulatory support for new products and changes to existing products. Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Preparation and maintenance of annual renewals of Establishment Registrations, State Manufacturing licenses, Device Listing, and other pertinent domestic and international licensing.
Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements.
Review complex reports, validations, etc. for scientific merit and regulatory appropriateness.
Determination of regulatory submission requirements according to domestic and international regulations related to changes/new products/claims.
Maintain/Index/Organize Regulatory library.
Maintain technical knowledge of devices in area of responsibility.
Maintain up-to-date on global regulatory requirements and assist in keeping company informed of regulatory requirements.
Review/Prepare Standard Operating Procedures (SOPs) as needed.
Perform additional duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
Thorough understanding of FDA and international regulations.
Strong working knowledge of medical devices regulations and terminologies.
Excellent written and oral communication, and technical writing and editing skills.
Ability to write clear, understandable technical documentation.
Skilled at analyzing and summarizing data.
Proficient with Microsoft Office.
Ability to manage and prioritize multiple projects.
Ability to follow written and verbal directions with a high level of accuracy.
Ability to work independently with minimal supervision.
Extreme attention to detail.
Ability to work in a team setting.
Ability to effectively manage multiple projects and priorities.
Effective interpersonal skills.
REQUIRED EDUCATION AND EXPERIENCE:
Bachelor's Degree in chemistry, scientific or engineering discipline
Minimum 2 to 4 years related experience, or equivalent combination of education and experience, required.
Knowledge of Medical Device Quality Systems (21 CFR 820, ISO 13485)
PREFERRED EDUCATION AND EXPERIENCE:
RAC Certification (desirable)
International medical device regulatory submission/approval experience including EU, Japan and China
Must be able to remain in a stationary position at least 50% of the time.
Must be able to travel to the office on occasion, if working remotely. Additional travel may include travel to trainings and surgery sites.
Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
Ability to listen and speak with others. Must be able to exchange accurate information in these situations.
View and type on computer screens for long periods of time.
This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
New World Medical's mission is to preserve and enhance vision by delivering innovations to benefit humanity. We are committed to leading the ophthalmic industry in the treatment of glaucoma and are determined in providing eye care professionals with the most advanced, cutting-edge technologies in order to alleviate the suffering of glaucoma patients around the world.