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Bard Peripheral Vascular
Tempe, AZ, United States

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Regulatory Affairs Specialist - MEDICAL DEVICE TECHNOLOGY -- Tempe, AZ - Job ID: 2017-10928


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Job ID:

3568276

Location:

Tempe 

Job Category:

Biotech, Engineering, Health Care
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States:

AZ

Employment Type:

Full Time

Posted:

01.16.2018
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Job Description:

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.

 

Summary of Position with General Responsibilities:

This position is responsible for the development and implementation of CE Marking for International documentation such as Design Dossiers and Technical Files. The candidate will be expected to review and summarize published literature as it relates to the CE Marked product. Knowledge of the Medical Device Regulation is preferred.

Essential Job Functions:

  1. Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory submissions plan around product development/line extension goals.
  2. Prepares U.S. FDA submissions (e.g., 510(k), IDE) as required and per applicable SOPs.
  3. Prepares and updates European and international technical files/dossiers/registrations as required and per applicable SOPs. Performs gaps of legacy products against the Medical Device Regulation.
  4. Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.
  5. Represents Bard Peripheral Vascular in corporate working groups.
  6. Ensures adequate documentation of Bard Peripheral Vascular’s compliance to FDA, European and international regulations and standards. Ensures continuous update and maintenance of the Regulatory Affairs files.
  7. Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Bard Peripheral Vascular’s notified body.     

Job Requirements:

Basic Qualifications:

  1. Working knowledge of U.S., European and/or global regulations and standards covering medical devices.
  2. Minimum of 2 years of RA related experience.
          
Additional Desirable Qualifications Skills and Knowledge:
  1. Excellent communication (both verbal and written) skills.
  2. Sufficient computer skills (Windows environment).
  3. Good problem-solving and analytical skills. 
  4.  Detail oriented with strong Excel knowledge. Ease with manipulation of data.

Education and/or Experience:
  1. Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field.
  2. 510(k) submission experience required. PMA submission experience a plus.
 

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:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

Security Clearance:

NO Security Clearance




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