Project Manager - Regulatory Affairs

Montvale, NJ

Post Date: 05/26/2017 Job ID: 7528 Industry: Office Pay Rate: $75,000 - $85,000/yr.

SUMMARY
Develops, documents and implements Regulatory Processes to support the GI Endoscope and Speech, Voice and Swallowing businesses. Assures that regulatory processes are characterized and supported by company procedures. Provides Project Management support for Regulatory initiatives as well as subject matter expertise in product registration and associated regulatory processes. Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas. Provide training and support to other members of the department.

RESPONSIBILITIES

  • Maintain Quality System registration and assure CE Marking for SVS Products



  • Manages Notified Body interface, contracts, logistics



  • Supports the OUS Registration program for the SVS product line IAW Global Regulatory Strategy



  • Maintains the global registration status of the SVS product line, tracking expiration and re-registration



  • Supports the Canada and LATAM registration of the GI product line



  • Manages the Field Safety Corrective Action program



  • Manages the Establishment Registration and Device Listing process



  • Manages UDI Program implementation



  • Submission Priority Project Management



  • Submission and Compliance Project Management - Develops, implements and manages systems to track required reports, supplemental submissions and postmarketing commitments.



  • Regulatory Process Owner for Digital Asset Management of Claims Collateral



  • Process Owner for Project Management Process, maintaining SOP/Work Instructions/Forms and providing training



  • Develops and executes new Regulatory procedures and Work Instructions



  • Regulatory support for business systems (ERP etc.)



  • Identifies regulatory pathways for initial product designs and provides input to internal stakeholders.



  • Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.



  • Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, IDN s, etc.) and develops solutions to address anticipated obstacles.



  • Critically assesses the impact of changing regulations on preapproval and postapproval strategies and approaches and advises internal stakeholders on a course of action.



  • Approves and executes changes to preapproval and post-approval strategies and approaches based on changing regulations.



  • Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products.



  • Negotiates with regulatory authorities on complex issues throughout the product lifecycle.



  • Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.



  • Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).



  • Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance




QUALIFICATIONS

  • BA and/or BS degree in Science, Engineering or equivalent, Master s degree preferred



  • Minimum of 4 year s regulatory affairs experience



  • Knowledge of FDA requirements, guidance documents, 510(k) submissions, Medical Device Directive, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards involvement with regulatory submissions, interactions with regulatory agencies (e.G., FDA), and working with cross-functional project teams.



  • Knowledgeable in device submissions



  • Knowledge of GLP/GCP requirements



  • Familiarity with regulatory requirements and standards governing global manufacturing and distribution of FDA regulated products;



  • Detail oriented, high degree of accuracy, deadline driven;



  • Strong organizational skills with the ability to actively contribute to new projects;



  • Excellent communication, interpersonal and time management skills;



  • Flexibility in the ability to prioritize, multi task, and learn quickly with a positive attitude.



  • Strong negotiation skills and written/oral communication skills



  • Strong organizational skills and time management skills



  • Ability to support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines



  • Ability to work independently and under general direction only



  • Computer skills; MS Office, MS Project, Adobe Acrobat

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