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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: 2017-9920


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Job ID:

3568277

Location:

Tempe 

Job Category:

Biotech, Engineering, Health Care
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States:

AZ

Employment Type:

Full Time

Posted:

04.20.2017
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Job Description:

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. #LI-SF1

 

Summary of Position with General Responsibilities:

The Regulatory Affairs Specialist (RAS) demonstrates ability to create and communicate global regulatory requirements thoughout the product lifecycle working closely with a cross functional team. The RAS is able to interpret and communicate regulatory changes to ensure the business is aware of opportunities, risks and issues. The RAS is responsible for ensuring compliance with the regulations and Bard Peripheral Vascular's processes and procedures. The RAS utilizes project planning skills to initiate, plan, execute, and manage regulatory projects and submissions. The RAS manages change and is flexible when providing solutions. The RAS demonstrates collaboration with their regulatory team, cross functional team members, and regulatory agency parners by building strong and effective working relationships.  

 

Essential Job Functions:

  1. Understands and has working knowledge of FDA medical device regulations, European Medical Device Directives, and/or other global regulations.
  2. Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around product development goals.
  3. Prepares U.S. FDA submissions (e.g., 510(k), IDE, PMA) as required and per applicable SOPs.
  4. Initiates and updates technical files/dossiers/registrations as required and per applicable SOPs.
  5. Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards.
  6. Ensures adequate documentation of Bard Peripheral Vascular’s compliance to FDA, European and global regulations and standards. Ensures 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.
  8. Works with the regulatory mangament team to ensure compliance with Corporate Regulatory.
 

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. Proven computer software skills (Windows Word, Excel, Powerpoint, Project, Outlook).
  3. Demonstrated problem-solving and analytical skills.  
  4. Solid project management skills.
  5. Experience working with others in a team environment.
 

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.

CLICK ON LINK BELOW TO BE DIRECTED TO OUR WEBSITE FOR YOUR APPLICATION PROCESS: https://jobs-crbard.icims.com/jobs/9920/regulatory-affairs-specialist/job

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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