Regulatory Affairs Specialist

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.

KNOWLEDGE, SKILLS AND ABILITIES:

• Thorough understanding of FDA and international regulations.
• Strong working knowledge of medical devices regulations and terminologies. Ophthalmic devices are a plus.
• Experience in risk management and design control in medical devices is a plus.
• 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.

REQUIRED EDUCATION AND EXPERIENCE:

• 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.

PREFERRED CERTIFICATION AND EXPERIENCE:

• RAC Certification 
• International medical device regulatory submission/approval experience including EU, Japan and China

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time, including sitting at a desk and working on a computer.
• Occasionally move about inside the office and travel to and from office buildings. This may include, but is not limited to, bending and walking.
• Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
• Occasionally lift up to 15 pounds. This may be performed with reasonable accommodation.
• 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.