REGULATORY SOFTWARE PROJECT MANAGER (31915)

Description

• This will be a local remote position and you must reside within 125 miles of Jacksonville, FL**
  
  

Who We Are

At KLS Martin, we offer a unique opportunity to contribute to the success of a dynamic and thriving company whose products are used daily across the world to help surgical patients.

The KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields. Surgical innovation is our passion, and we are constantly working with surgeons to improve surgical care for their patients. Our product portfolio includes titanium and resorbable implants for reconstruction, innovative distraction devices to stimulate bone lengthening, over 4,000 surgical instruments, and other surgical products designed specifically for CMF and cardiothoracic surgeons.

KLS Martin is an innovative leader in the treatment of CMF deformities and trauma cases. We use Individual Patient Solutions (IPS) by using our proprietary IPS products where CT scans are used to custom design implants that are created specifically for that individual patient. This technology allows our surgeons to provide the best-in-class treatment for their patients.

KLS Martin Guiding Principles

• Established, Privately Held Business Group – Responsive to customers, not shareholders. KLS Martin has manufactured medical products since 1896, and we have sold our products in the United States under the KLS name since 1993. We have always been, and always will be, privately owned.
• Patient Focus – We design products with the patient in mind – CMF, Thoracic & Hand
• Product to Table – Integrated planning, design, manufacturing and distribution process
• Educational Partner – Our primary focus for support is on education
• Inventory Alliance – Inventory management is critical to patient treatment/outcome
• Surgical Innovation is Our Passion – More than just a tagline
  
  

What We Offer

• We provide full-time employees with a competitive benefits package, including paid parental leave
• In-house training and professional development opportunities
• A culture of creativity and innovation by drawing on diverse perspectives and ideas to drive surgical innovation
  
  

Job Summary

The RA/QMS Software Specialist is responsible for working with cross-functional teams to develop and implement risk-based medical device compliance for KLS Martin L.P. North America for software. Consult with teams on the review, assessment, and resolution of issues relating to all aspects of the Software Lifecycle for development projects, regulatory submissions and production processes. Exercises discretion and independent judgement related, but not limited to, domestic and international regulatory submissions and interfacing with regulatory authorities on the submissions.

Essential Functions, Duties, And Responsibilities

• Execute oversight over software compliance for production and development of products.
• Supports design and development process to include design history file as software subject matter expert for KLS-Martin L.P. and KLS Martin Manufacturing.
• Assess product change requests and impact on software with respect to regulatory and quality.
• Support and facilitate SaMD development activities with vendor as FDA software liaison.
• Execute a risk-based approach to software needs for production and quality system.
• Ensure documents are produced in accordance with standard operating procedures, internal and external guidelines and company templates.
• Participate in regulatory audits related to software requirements.
• Provide strategic direction to the research and development team with projects involving software and oversight of vendor applications.
• Design, develop, document, and maintain processes and procedures to ensure that compliance to FDA and Health Canada requirements, standards, and guidance.
• Research software issues and provides supervision, guidance, and advice to cross functional team members.
• Stay up to date on applicable software industry guidance to ensure efficient approach to meet necessary requirements.
  
  

Qualifications

Educational and Experience Requirements

• 4 year degree in a relevant field, e.g., Bio-engineering, Life Sciences, Regulatory Affairs, or related discipline. Master’s degree preferred
• Minimum of 5-years’ experience in medical device compliance, with expertise and demonstrable experience in medical device software compliance.
• Strong knowledge of FDA, ISO 13485, ISO 14971, IEC 62304
  
  

Knowledge, Skills, And Abilities

• Ability to coordinate or manage multiple projects to meet project timelines/milestones.
• Exercises independent judgment with problem-solving skills.
• Ability to understand and discuss relevant requirements with respect to software and medical device.
• Broad knowledge and understanding of the design and critical review of FDA and Health Canada requirements with respect to software.
• Excellent level proficiency with word processing (Word), spreadsheets (Excel), presentation programs (Power Point).
• Solid written and verbal communication skills, analytical ability and problem-solving skills that enable you to work on international cross functional teams
• Strong ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Strong attention to detail and organizational skills
  
  

Skill Requirements

• Typing/computer keyboard
• Utilize computer software (specified above)
• Retrieve and compile information
• Verify data and information
• Organize and prioritize information/tasks
• Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
• Verbal communication
• Written communication
• Public speaking/group presentations
• Research, analyze and interpret information
• Investigate, evaluate, recommend action
• Basic mathematical concepts (e.g. add, subtract)
• Abstract mathematical concepts (interpolation, inference, frequency, reliability, formulas, equations, statistics)
  
  

Physical Requirements

• Sitting for extended periods
• Extended periods viewing computer screen
• Walking
• Reading
• Speaking
• Hear/Listen
• Maintain regular, punctual attendance
• Writing
  
  

Hazards

• Normal office environment
  
  

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

KLS Martin is a drug-free employer

Description

• This will be a local remote position and you must reside within 125 miles of Jacksonville, FL**
  
  

Who We Are

At KLS Martin, we offer a unique opportunity to contribute to the success of a dynamic and thriving company whose products are used daily across the world to help surgical patients.

The KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields. Surgical innovation is our passion, and we are constantly working with surgeons to improve surgical care for their patients. Our product portfolio includes titanium and resorbable implants for reconstruction, innovative distraction devices to stimulate bone lengthening, over 4,000 surgical instruments, and other surgical products designed specifically for CMF and cardiothoracic surgeons.

KLS Martin is an innovative leader in the treatment of CMF deformities and trauma cases. We use Individual Patient Solutions (IPS) by using our proprietary IPS products where CT scans are used to custom design implants that are created specifically for that individual patient. This technology allows our surgeons to provide the best-in-class treatment for their patients.

KLS Martin Guiding Principles

• Established, Privately Held Business Group – Responsive to customers, not shareholders. KLS Martin has manufactured medical products since 1896, and we have sold our products in the United States under the KLS name since 1993. We have always been, and always will be, privately owned.
• Patient Focus – We design products with the patient in mind – CMF, Thoracic & Hand
• Product to Table – Integrated planning, design, manufacturing and distribution process
• Educational Partner – Our primary focus for support is on education
• Inventory Alliance – Inventory management is critical to patient treatment/outcome
• Surgical Innovation is Our Passion – More than just a tagline
  
  

What We Offer

• We provide full-time employees with a competitive benefits package, including paid parental leave
• In-house training and professional development opportunities
• A culture of creativity and innovation by drawing on diverse perspectives and ideas to drive surgical innovation
  
  

Job Summary

The RA/QMS Software Specialist is responsible for working with cross-functional teams to develop and implement risk-based medical device compliance for KLS Martin L.P. North America for software. Consult with teams on the review, assessment, and resolution of issues relating to all aspects of the Software Lifecycle for development projects, regulatory submissions and production processes. Exercises discretion and independent judgement related, but not limited to, domestic and international regulatory submissions and interfacing with regulatory authorities on the submissions.

Essential Functions, Duties, And Responsibilities

• Execute oversight over software compliance for production and development of products.
• Supports design and development process to include design history file as software subject matter expert for KLS-Martin L.P. and KLS Martin Manufacturing.
• Assess product change requests and impact on software with respect to regulatory and quality.
• Support and facilitate SaMD development activities with vendor as FDA software liaison.
• Execute a risk-based approach to software needs for production and quality system.
• Ensure documents are produced in accordance with standard operating procedures, internal and external guidelines and company templates.
• Participate in regulatory audits related to software requirements.
• Provide strategic direction to the research and development team with projects involving software and oversight of vendor applications.
• Design, develop, document, and maintain processes and procedures to ensure that compliance to FDA and Health Canada requirements, standards, and guidance.
• Research software issues and provides supervision, guidance, and advice to cross functional team members.
• Stay up to date on applicable software industry guidance to ensure efficient approach to meet necessary requirements.
  
  

Qualifications

Educational and Experience Requirements

• 4 year degree in a relevant field, e.g., Bio-engineering, Life Sciences, Regulatory Affairs, or related discipline. Master’s degree preferred
• Minimum of 5-years’ experience in medical device compliance, with expertise and demonstrable experience in medical device software compliance.
• Strong knowledge of FDA, ISO 13485, ISO 14971, IEC 62304
  
  

Knowledge, Skills, And Abilities

• Ability to coordinate or manage multiple projects to meet project timelines/milestones.
• Exercises independent judgment with problem-solving skills.
• Ability to understand and discuss relevant requirements with respect to software and medical device.
• Broad knowledge and understanding of the design and critical review of FDA and Health Canada requirements with respect to software.
• Excellent level proficiency with word processing (Word), spreadsheets (Excel), presentation programs (Power Point).
• Solid written and verbal communication skills, analytical ability and problem-solving skills that enable you to work on international cross functional teams
• Strong ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Strong attention to detail and organizational skills
  
  

Skill Requirements

• Typing/computer keyboard
• Utilize computer software (specified above)
• Retrieve and compile information
• Verify data and information
• Organize and prioritize information/tasks
• Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
• Verbal communication
• Written communication
• Public speaking/group presentations
• Research, analyze and interpret information
• Investigate, evaluate, recommend action
• Basic mathematical concepts (e.g. add, subtract)
• Abstract mathematical concepts (interpolation, inference, frequency, reliability, formulas, equations, statistics)
  
  

Physical Requirements

• Sitting for extended periods
• Extended periods viewing computer screen
• Walking
• Reading
• Speaking
• Hear/Listen
• Maintain regular, punctual attendance
• Writing
  
  

Hazards

• Normal office environment
  
  

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

KLS Martin is a drug-free employer