REMOTE Sr Application Analyst Regulatory Affairs

Date: May 6, 2022

Location: Naples, FL, US, 34108

Company: Arthrex

Requisition ID: 53669 
Title: Sr Application Analyst Regulatory Affairs 
Division: Arthrex, Inc. (US01) 
Location: Naples, FL

 

 

 

 

 

 

 

 

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Sr Application Analyst Regulatory Affairs to work directly with the IT & Regulatory Affairs departments within Arthrex to manage a pipeline of Information Technology projects and enhancements. The position liaises with other technical organizations to deliver innovative and value-driven business solutions. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

We would like this position to sit with us in our Corporate Headquarters in Naples to work directly with the team with a partial-flexible WFH policy in effect.  Generous relocation package offered!  However, this could be a remote position in the USA for the right person.

 

Essential Duties and Responsibilities:

  • Translate business goals and objectives into strategic business capabilities.  
  • Develops roadmaps that defines business strategy; facilitates identification of key business strategy elements.
  • Analyze business process requirements and develop functional/system specifications.
  • Document system architecture and define application components, platforms, interfaces, and development tools.
  • Ensures that the solution meets all non-functional requirements like Security, Scalability, Reliability, etc.
  • Articulate design considerations, trade-offs, benefits, and recommendations for technical solutions with scalability and supportability in mind.
  • Collaborate with internal and external technical resources performing analysis, design, configuration, development, testing, and deployment activities for applications.
  • Provide technical guidance to application development teams, consult on integration and conversion issues and participate in mapping technology-independent application architecture to the chosen technology platform.
  • Ensures adoption of consistent processes, strategies and technology. Helps perpetuate the envisioned change a program/project will cause.
  • Conduct research on emerging technologies in support of objectives and recommend technologies that will increase cost effectiveness, flexibility, and innovation
  • Focus on the long-term architecture and strategy for solutions that enable operations.
  • Define, champion and govern business standards, tools, best practices, and development methodologies.
  • Up to 20% travel required

 

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

 

Education and Experience:

  • Bachelor’s Degree required.  Degree in Computer Science or related field preferred. Master’s Degree preferred
  • At least Five (5) years’ experience within Quality or Regulatory business functions with exposure to design release, management of technical documentation, and submission for product registration to Health Authorities.
  • Previous involvement in the deployment or optimization of SAP or other Product Lifecycle Management (PLM) technologies.
  • Previous involvement in the deployment or optimization of Regulatory Information Management Systems (RIMS)
  • Previous position in Pharma or Medical Device industry.

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • In depth knowledge of several business functions and related software applications.  SAP or Oracle preferred.
  • Experience with process improvement techniques and tools. Lean or Six Sigma preferred.
  • Understanding of the major functions in a global organization.
  • Strong communication (written and oral) and presentation skills.
  • Ability to work comfortably at all levels within the organization up to the senior management level.

 

Machine, Tools, and/or Equipment Skills:

PC servers, workstations and laptops. Telecommunication equipment, cell phones and smart phones. Microsoft and Apple environment. Work with standard current computer applications, such as word processing, spreadsheets and data bases. MS Office, SQL server, Active Directory, MS Exchange, ERP and partner software applications.

This is an in-office position located in Naples, Florida; it is not a remote position.

#LI-KL1

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


Nearest Major Market: Naples

Job Segment: PLM, Medical Device, Six Sigma, Lean Six Sigma, Computer Science, Management, Healthcare, Technology