What are the responsibilities and job description for the REGULATORY AFFAIRS PROJECT MANAGER, MEDICAL DEVICES position at KLS Martin Group?
**This will be a local REMOTE position However, you must reside within 125 miles of Jacksonville, FL, due to the *occasional in-office responsibilities. **
Who We Are
The KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields.
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.
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
Research 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
Research 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
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Ready to bring your expertise to a growing team? Let's talk!
Please send CV to: Dawn.Ruiz@klsmartin.com for review and immediate scheduling !!
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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
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Relocation assistance
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: Hybrid remote in Jacksonville, FL 32246