Regulatory Affairs Project Manager (34110)

KLS MARTIN LP•Jacksonville, FL

22h

About The Position

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.

Requirements

4-year degree plus 6 years work experience in a regulated industry, OR 8 years of experience in regulated industry
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
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
Sitting for extended periods
Extended periods viewing computer screen
Walking
Reading
Speaking
Hear/Listen
Maintain regular, punctual attendance
Writing

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.