Regulatory Affairs Specialist I

Job Summary

In this high profile role, the Regulatory Affairs Specialist I will be an integral part of an expanding regulatory affairs team that is responsible for maintaining and documenting our mission critical domestic and international regulatory filings and registrations. From coordinating with international regulatory team members on product changes to maintaining up-to-date information on domestic regulatory requirements, the incumbent will be a key person in making it happen. The incumbent's medical device regulatory expertise, organizational ability, and multi-tasking skills will be rewarded with opportunities for career growth and advancement in a company that makes a difference in people's lives.

Duties & Responsibilities

• Support the regulatory team managing international and domestic filings/registrations;
• Coordinate with international regulatory team members on product changes and regulatory notification / approval requirements;
• Assist in maintaining product list on Certificate of Foreign Government;
• Maintain up-to-date knowledge on international and domestic regulatory requirements;
• Generate and maintain product compliance checklists;
• Provide regulatory support to the OEM Deployment group;
• Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports;
• Submit document change orders (DRO/agile) for approvals;
• As requested by supervisor, represent RA department in project meetings and provide regulatory guidance;
• Update RA responsible quality system procedures as required (SQP/SOP's);
• Performs other duties or special projects as assigned;
  
  
  
  • Computer Proficiency with MS Office (Word/Excel/Access/Outlook);
  
  

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• Excellent verbal and written communication skills;
• Excellent prioritizing, organizational, and interpersonal skills;
• Excellent documentation skills including record maintenance/tracking and understand document traceability;
• A detail-oriented individual with a "can do" attitude;
• Ability to work in a team environment as well as individually with minimal supervision;
• Ability to work in a fast-paced , Project Team environment, with multiple tasks/projects;

Preferred Qualifications

• Some previous work experience in a medical device Class II/ III environment;
• Experience in patient monitor systems, hospital-based products, software or electronic device products;
  
  
  
  • Knowledge of regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission;
  • Experience with FDA/GMP requirements for medical device;
  • Experience in Quality Systems, per ISO 13485;
  
  
• Experience with the UL/ETL certification process;
  
  
  
  • Experience interacting with regulatory bodies, such as the Notified Body;
  
  

Education

BA/BS Degree is required, preferably in life sciences, engineering or business

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.