C. R. Bard, Inc.

Regulatory Affairs Manager

Posted Date 3 weeks ago(1/30/2018 11:22 AM)
Industry / Category
Medical Device
Job ID
2018-11084
Career Level
management
Division
BPV/Tempe
Relocation
Yes
Location
US-AZ-Tempe

Overview

Bard Peripheral Vascular is located Tempe, AZ – where a tradition of vascular innovation spans decades of focusing on improving the quality of patients’ lives. From C. R. Bard’s first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for peripheral vascular patency, while providing exceptional service and support to surgeons, interventionalists and radiologists. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. #LI-JC1

Summary of Position with General Responsibilities

This senior position is responsible for the creation of global regulatory strategy while working with a cross-functional team in accordance with global regulations and quality standards.  This individual acts as a regulatory lead and advisor on project teams.

Essential Job Functions

  • Manage, plan, and coordinate work of Regulatory Affairs department.
  • Participate in product development teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document, and implement a regulatory submission plan around product development/line extension goals.
  • Prepare U.S. FDA 510(k), IDE, PMA, submissions as required. Ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, and scientifically based.
  • Prepare and update European and international product dossiers/registrations as required. Ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, and scientifically based.
  • Review Engineering Change Orders for compliance with FDA, European, and international regulations and standards.
  • Coordinate the review of promotional material.
  • Develop/update Stand Operating Procedures (SOPs) implementing FDA, European, and international regulations and standards as appropriate.
  • Ensure adequate documentation of BPV’s compliance to FDA, European, and international regulations and standards. Ensure continuous update and maintenance of the Regulatory Affairs files.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification, and follow-up of submissions under review.

Supervisor/Management Responsibilities:

Management of multiple individuals within the regulatory department.

Fiscal/Budgetary Responsibilities:

The ability to accomplish job functions within a specified budget that may fluctuate depending on the project.  No direct budgeting responsibilities initially with the position; however, this may be adapted based on the aptitude of the individual.

Customer and Key Contacts: 

  • Ability to work with a variety of multidisciplinary internal and external customers.
  • Ability to work independently with minimal supervision and accountable for managing multiple projects concurrently.
  • Ability to communicate with FDA and EU Notified Bodies.

Basic Qualifications

  • Excellent communication skill, both written and verbal, as well as good interpersonal, problem solving, and analytical skills.
  • Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices.
  • Knowledge of the clinical application of medical devices, as applicable.
  • Knowledge of medical device testing methods and statistics, as applicable.
  • Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.
  • Team player, able to serve on project teams as needed.
  • Sufficient computer skills (e.g., MS Word, MS Excel, MS PowerPoint, etc.).

Education and/or Experience

  • Minimum of four years Regulatory Affairs related experience.
  • Minimum of one year supervisory experience.
  • Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering, or medical-related field.

Physical Demands

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.  The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

Work Environment

Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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