Regulatory Affairs Specialist

New World Medical•Rancho Cucamonga, CA

14d•$85,000 - $96,000

About The Position

JOB SUMMARY: The Regulatory Affairs Specialist (RAS) 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, assists in preparing regulatory submissions, and negotiates their approval with regulatory agencies as required. Primary responsibilities include preparing International and US regulatory submissions; preparing Technical File, providing documentation for international submissions; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables. ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: Support the development of regulatory planning and strategies for product submissions in US and International market. Partner with business unit to provide regulatory support for new products and changes to existing products. Collaborate with other Regulatory Peers and other department cross functional teams to resolve potential regulatory issues and questions from regulatory agencies. Assist in preparing FDA submissions and CE Mark Technical Files and other international Design Dossiers for product changes and/or new products as required to ensure timely approvals for global market and relevant FDA and ISO requirements are met, as required. Review Change Orders and assess regulatory & labeling impact of product changes on US and International regulatory planning and submissions. Preparation and maintenance of annual renewals of Establishment Registrations, State Manufacturing licenses, Device Listing, and other pertinent domestic and international licensing. Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing and provide regulatory support when needed. 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. Evaluates current QMS, technical documentation, and clinical data against standards ISO and regulations (EU MDR, FDA, etc.) to identify and complete compliance gaps. Maintain/Index/Organize Regulatory library. Maintain technical knowledge of devices in area of responsibility. Maintain up-to-date knowledge on global regulatory requirements and assist in keeping company informed of regulatory requirements. Review/Prepare and maintain department’s Standard Operating Procedures (SOPs) and Work Instructions/Templates as needed. Perform additional duties as assigned.

Requirements

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.
Enjoys learning rules and applying them in practical ways.
Proficient with Microsoft Office Suite.
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 in a constantly changing and dynamic setting.
Extreme attention to detail.
Ability to work in a team setting.
Ability to stay calm and focus under strict deadlines.
Effective interpersonal skills.
Minimum Bachelor’s degree in a scientific/engineering related field or equivalent combination of education/experience.
Minimum 2 to 4 years related experience, or equivalent combination of education and experience, required.
Knowledge of Medical Device FDA Quality Systems Regulation (21 CFR 820), ISO 13485, and EU MDR are a plus.

Nice To Haves

Ophthalmic devices are a plus.
Experience in risk management and design control in medical devices is a plus.
RAC Certification
International medical device regulatory submission/approval experience including EU, Japan and China

Responsibilities

Support the development of regulatory planning and strategies for product submissions in US and International market.
Partner with business unit to provide regulatory support for new products and changes to existing products.
Collaborate with other Regulatory Peers and other department cross functional teams to resolve potential regulatory issues and questions from regulatory agencies.
Assist in preparing FDA submissions and CE Mark Technical Files and other international Design Dossiers for product changes and/or new products as required to ensure timely approvals for global market and relevant FDA and ISO requirements are met, as required.
Review Change Orders and assess regulatory & labeling impact of product changes on US and International regulatory planning and submissions.
Preparation and maintenance of annual renewals of Establishment Registrations, State Manufacturing licenses, Device Listing, and other pertinent domestic and international licensing.
Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing and provide regulatory support when needed.
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.
Evaluates current QMS, technical documentation, and clinical data against standards ISO and regulations (EU MDR, FDA, etc.) to identify and complete compliance gaps.
Maintain/Index/Organize Regulatory library.
Maintain technical knowledge of devices in area of responsibility.
Maintain up-to-date knowledge on global regulatory requirements and assist in keeping company informed of regulatory requirements.
Review/Prepare and maintain department’s Standard Operating Procedures (SOPs) and Work Instructions/Templates as needed.
Perform additional duties as assigned.