Sr. Project-Program Manager, Regulatory Affairs

Date: Jun 16, 2024

Location: Naples, FL, US, 34108

Company: Arthrex

 Requisition ID:                       60142                         
Title: Sr. Project-Program Manager, Regulatory Affairs
Division: Arthrex, Inc. (US01)
Location: Naples, FL

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Project Manager, Program Manager – Regulatory Affairs who is responsible for managing and resolving issues related to the time, budget, and resource allocation for a given program or project. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Essential Duties and Responsibilities:

  • Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs.
  • Develops project objectives by reviewing project proposals and business plans, conferring with senior management and key stakeholders.
  • Determines project schedule by studying project plan and specifications, calculates time requirements, identifying and sequencing project elements and discreet tasks.
  • Maintains project schedule by monitoring project progress, coordinating activities, and resolving risks or obstacles.
  • Determines project responsibilities by identifying project phases and elements, requesting and allocating resources as necessary.
  • Ensure project progresses within the boundaries of the approved scope. Manage the scope of the project and guarantee scope changes are properly documented and implemented.
  • Identify opportunities for improvement within regulatory processes to improve efficiency and speed-to-market.
  • Monitor resource capacity within Regulatory Affairs and cross-functional resources, and communicate constraints or needs to senior management.
  • Help facilitate, with interdepartmental managers, the availability, assignment, and accountability of downstream resources and technology.
  • Help facilitate project, program and portfolio status to management and key stakeholders with applicable metrics and project constraints.

Education and Experience:

  • Bachelor’s degree in relevant field such as business administration
  • 5 Years Relevant Experience

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Working knowledge of ISO and FDA design and development quality requirements.

Technical knowledge in development methodologies, design quality analysis, and project implementation.

Proficiency in assessing manufacturing quality requirements of new product concepts.

Technical knowledge in development methodologies, design, and project implementation, including but not limited to, GD&T & DOE preferred.

 

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalent if changed by the Company), QAD or similar inventory software.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills:

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures

 

 

Arthrex Benefits

  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)

 

 

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


Nearest Major Market: Naples

Job Segment: Program Manager, Medical Device, Project Manager, Quality Assurance, QA, Management, Healthcare, Technology, Quality