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Bard Peripheral Vascular
Tempe, AZ, United States

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Senior Regulatory Affairs Specialist - MEDICAL DEVICE TECHNOLOGY -- Tempe, AZ - Job ID: 2017-9922


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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:

09.19.2017
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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. #LI-SF1

 

Summary of Position with General Responsibilities:

The Senior Regulatory Affairs Specialist (Sr RAS) demonstrates ability to lead multiple projects including new project development and post market requirements. The Sr RAS will create and communicate global regulatory requirements thoughout the product lifecycle working closely with a cross functional team. The Sr Sr RAS is able to mentor junior team members to help them understnd regulatory processes and strategies. The Sr RAS is knowledgeable in global regulations and is able to interpret and communicate regulatory changes to ensure the business is aware of opportunities, risks and issues. The Sr RAS is responsible for ensuring compliance with the regulations and Bard Peripheral Vascular's processes and procedures. The Sr RAS has proven project planning skills to initiate, plan, execute, and manage multiple regulatory projects and submissions. The Sr RAS manages change and is flexible when providing solutions. The Sr RAS demonstrates collaboration with their regulatory team, cross functional team members, and regulatory agency partners 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. Proven track record in authoring FDA submissions, i.e., Investigational Device Exemptions, Premarket Applications, and 510(k) submissions.
  3. Project management experience with specific responsibilities in managing complex projects.
  4. Experience with FDA/Notified Body regulatory audit inspections.
  5. Participated as primary regulatory lead in product core teams as required to ensure that the new product development is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around product development goals. Drive timelines and is able to articulate results and expectations in professional manner.
  6. Initiates and updates technical files/dossiers/registrations as required and per applicable SOPs.
  7. Ensures adequate documentation of Bard Peripheral Vascular’s compliance to FDA, European and global regulations and standards. Ensures maintenance of the Regulatory Affairs files.
  8. 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.
  9. Works with the regulatory mangament team to ensure compliance with Corporate Regulatory.
  10. Participate on cross corporate project improvement teams when requested.
 

Job Requirements:

Basic Qualifications:

  1. Working knowledge of U.S., European and/or global regulations and standards covering medical devices.
  2. Minimum of 5-7 years of RA related experience specifically Class II and Class III medical devices.
  3. 510(k) submission experience required. PMA submission experience a plus.            
 

Additional Desirable Qualifications Skills and Knowledge:

  1. Excellent communication (both verbal and written) skills.
  2. Able to work in a dynammic environment with shifting timelines and priorities.
  3. Proven computer software skills (Windows Word, Excel, Powerpoint, Project, Outlook).
  4. Demonstrated problem-solving and analytical skills.
  5. Willingness to share knowledge and work with junior team members.
  6. Solid and proven project management skills.
  7. 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. 5-7 years of regulatory related experience with specific experience in Class II and Class III medical devices.
  3. 3. 510(k) submission experience required. PMA submission experience a plus.      
CLICK ON LINK BELOW TO BE DIRECTED TO OUR WEBSITE FOR YOUR APPLICATION PROCESS: https://jobs-crbard.icims.com/jobs/9922/senior-regulatory-affairs-specialist/job
 

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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