**This will be a local remote position and you must reside within 125 miles of Jacksonville, FL, due to in-office responsibilities.**
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
Responsible for leading project submission for regulatory approvals, acts to identify and resolve regulatory problems with respect to KLS-Martin L.P. and KLS Martin Manufacturing LLC. 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
Researches regulatory issues and provides supervision, guidance, and advice to cross functional team members
Reviews labeling/advertising for compliance and regulatory requirements for compliance with submissions
Oversight of design and development to include design history file as Regulatory Project Manager for KLS-Martin L.P. and KLS Martin Manufacturing product development process
Review and identify domestic and/or international regulatory pathways for initial product designs and recommend changes or refinements based on initial regulatory outcomes
Researches requirements (domestic and international) and provides options for regulatory submissions, approval pathways, and compliance activities
Tracks the status of applications under regulatory review and provides updates to the company
Execute domestic and international regulatory submissions, license renewals, and registrations to regulatory agencies
Assess product change requests for impact on regulatory filings
Builds strategic partnerships to further departmental and organizational objectives
Provide monitoring of the regulatory environment (specific regulations, guidance, and other relevant information by product types, geography, etc.) applicable to company products
Maintains positive and cooperative communications and collaborations
Performs other related duties and responsibilities, on occasion, as assigned
The above cited duties and responsibilities describe the general nature and level of work performed by people assigned to job. They are not intended to be an exhaustive list of all the duties and responsibilities that an incumbent may be expected or asked to perform. Qualifications
Education and Experience Requirements
4-year degree plus 6 years work experience in a regulated industry, or
10 years of experience in regulated industry
Knowledge, Skills, and Abilities
Maintains high integrity and confidentiality of company and department information
Ability to work effectively with all levels of internal and external associates, customers, and colleagues
Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem-solve
Ability to work with minimal supervision
Ability to manage multiple priorities
Ability to work both independently and within a team environment
Possess intermediate to advanced level knowledge of Microsoft Office and ERP systems
Skill Requirements:
Typing/Computer keyboard
Utilize computer software (specified above)
Retrieve and compile information
Verify data and information
Organize and prioritize information/tasks
Verbal communication
Written communication
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**This will be a local remote position and you must reside within 125 miles of Jacksonville, FL, due to in-office responsibilities.**
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
Responsible for leading project submission for regulatory approvals, acts to identify and resolve regulatory problems with respect to KLS-Martin L.P. and KLS Martin Manufacturing LLC. 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
Researches regulatory issues and provides supervision, guidance, and advice to cross functional team members
Reviews labeling/advertising for compliance and regulatory requirements for compliance with submissions
Oversight of design and development to include design history file as Regulatory Project Manager for KLS-Martin L.P. and KLS Martin Manufacturing product development process
Review and identify domestic and/or international regulatory pathways for initial product designs and recommend changes or refinements based on initial regulatory outcomes
Researches requirements (domestic and international) and provides options for regulatory submissions, approval pathways, and compliance activities
Tracks the status of applications under regulatory review and provides updates to the company
Execute domestic and international regulatory submissions, license renewals, and registrations to regulatory agencies
Assess product change requests for impact on regulatory filings
Builds strategic partnerships to further departmental and organizational objectives
Provide monitoring of the regulatory environment (specific regulations, guidance, and other relevant information by product types, geography, etc.) applicable to company products
Maintains positive and cooperative communications and collaborations
Performs other related duties and responsibilities, on occasion, as assigned
The above cited duties and responsibilities describe the general nature and level of work performed by people assigned to job. They are not intended to be an exhaustive list of all the duties and responsibilities that an incumbent may be expected or asked to perform.Education and Experience Requirements
4-year degree plus 6 years work experience in a regulated industry, or
10 years of experience in regulated industry
Knowledge, Skills, and Abilities
Maintains high integrity and confidentiality of company and department information
Ability to work effectively with all levels of internal and external associates, customers, and colleagues
Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem-solve
Ability to work with minimal supervision
Ability to manage multiple priorities
Ability to work both independently and within a team environment
Possess intermediate to advanced level knowledge of Microsoft Office and ERP systems
Skill Requirements:
Typing/Computer keyboard
Utilize computer software (specified above)
Retrieve and compile information
Verify data and information
Organize and prioritize information/tasks
Verbal communication
Written communication
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.
