Analyst Reg Aff

OVERALL RESPONSIBILITIES: 

Responsible for executing the submission process of product approval documents within the filing requirements. Expedites approval processing by addressing issues and ensuring compliance with government regulations and interpretations 

POSITION DUTIES & RESPONSIBILITIES: 

• Develops appropriate plans for the submission of product approval documents to ensure rapid and timely approval on medical devices and continued approved status of marketed medical devices.  

• Resolves moderately complex problems.  

• Provides regulatory support and expertise for moderately complex projects across all functional areas involved in projects.   

• Compiles moderately complex product approval packages. 

Functional and Technical Competencies: 

• Leverages a working knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to prepare compliant Regulatory strategies that are aligned with R&D and business objectives of the company, including consideration of the global regulatory environment. Executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status. 

• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives. 

• Is aware of and receptive to cultural differences across regions and countries. 

• Serves as a technical expert for low complexity projects within job function 

• Strong organizational skills 

• Project management skills 

• Problem solving skills 

• Fulfills competencies stated at the RA Global Competency Model as follows: 

• Applied Technical Knowledge – Applying 

• Business Acumen -  Learning 

• Decicion Making & Prioritization - Applying 

• External Focus – Learning 

• Leading and Influencing – Applying 

• Persuasive Communication - Applying 

• Bilingual Spanish - English 80% 

CEO Behaviors : 

• Compete – Be insight driven to uncover unmet needs, effectively influences others by partnering with them.Translates insights into viable processes and solutions that create value 

• Execute - Demonstrates conviction, proactivity and persistence when influencing others and overcoming resistance; gains support for one’s perspectives and ideas by establishing clear, positive links between ideas and business needs  

• Optimize – Manages low complexity projects independently 

EDUCATION & EXPERIENCE REQUIREMENTS: 

University/Bachelors Degree or Equivalent within a technical related discipline  

Generally requires 0-2 years related experience