Regulatory Affairs Specialist 2 CR

• Education:

• Bachelor’s degree engineering or related field or equivalent.

   

• Experience:
•  Minimum of 2 years’ experience in similar job position

• Specialized Knowledge (Desirable): 

• Strong working knowledge of medical device regulations (21CFR) and FDA law 

• Strong working knowledge of the regulatory requirements related to European medical device directives, additional experience with international registration requirements highly desirable 

• Capacity to communicate regulations to technical functions within the company 

• Ability to work with Regulatory Affairs Management to manage relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.) 

• Experience with document control systems such as Agile and Oracle 

• Medical device software submission and validation experience highly desirable

• Certified Regulatory Affairs Certified Professional (RAC) highly desirable

• Languages ​​required for the position (Desirable):

•  English and Spanish

                                                                                                                      

• Computer tools and knowledge level required (Desirable): 

• Microsoft Office: Intermediate Level 

• Internet: Yes      

• Email: Yes            

• Other Tools: Oracle

• Summary of Duties and Responsibilities: 

Respond to written questions from regulatory agencies as necessary.

Submit and follow-up on approval for product changes with regulatory agencies.

Maintain regulatory files for US and international submissions/documents.

Interpret existing or new US and international regulatory guidelines as they relate to company products, procedures, and policies.

Prepare/revise regulatory procedures as required.

Provide input to project teams to assure that FDA and other regulatory authority requirements are incorporated as part of the product development process.

Assist with international product registrations.

Retrieve guidelines and other regulatory information from the internet, FDA, and other appropriate sources

Attend appropriate regulatory meetings and maintain update on regulatory changes.

Interact with outside agencies such as FDA, Notified Bodies, international legal authorities, legal counsel, and other consultants.

Support the global regulatory team by leading LATAM regulatory activity

• Qualifications:

Listening

Problem Solving

Planning

Drive for Results

Peer Relations

Decision Quality