Job Description

Job Location: Jacksonville, FL 32246
Position Type: Full TimeEducation
Level: 4 Year Degree
Travel Percentage: None
Job Shift: DayJob

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
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.

QualificationsEducation and Experience Requirements
- 4-year degree plus 4 to 6 years' work experience in a regulated industry, OR
- 8 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