Job ID R-410525 Date posted 09/07/2021

Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
  • Glassdoor Reviews and Company Rating

Responsibilities

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Job Summary:

The Regulatory Affairs Specialist (RAS) demonstrates ability to create and communicate global regulatory requirements throughout 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 partners by building strong and effective working relationships.  

This role can be onsite in Tempe, AZ or can be 100% remote from anywhere within the US.

Responsibilities:

  • Understands and has working knowledge of FDA medical device regulations, European Medical Device Directives, and/or other global regulations.

  • 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.

  • Prepares U.S. FDA submissions (e.g., 510(k), IDE, PMA) as required and per applicable SOPs.

  • Initiates and updates technical files/dossiers/registrations as required and per applicable SOPs.

  • Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards.

  • Ensures adequate documentation of Bard Peripheral Vascular’s compliance to FDA, European and global regulations and standards. Ensures maintenance of the Regulatory Affairs files.

  • 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.

  • Works with the regulatory management team to ensure compliance with Corporate Regulatory.

Basic Qualifications:

  • Ability to plan and schedule multiple priorities in a concurrent fashion.

  • Ability to review, collate, and summarize scientific and technical data.

  • Ability to handle master documents, drawings, and specifications with a high degree of confidentiality.

  • Excellent problem solving and analytical skills.

  • Excellent written and oral communication skills.

  • Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.

  • Complete work with minimal supervision and have the ability to work independently.

  • Knowledge of U.S. and/or international medical device regulations.

Required Education and Experience:

  • Working knowledge of U.S., European and/or global regulations and standards covering medical devices.

  • Minimum of 3-5 years of experience, with 1-3 years RA related experience.

  • Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field.

  • 510(k) submission experience strongly desired. 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:

BD PI is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift

Apply

Success Profile

What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.

  • Analytical
  • Collaborative
  • Communicator
  • Persuasive
  • Problem-solver
  • Skilled presenter

Advancing the world of health™

BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.


Brian Carney
Staff Regulatory Affairs Specialist

I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job.


Robin Cassell
Global Regulatory Operations Labeling Specialist

I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on.


Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist

BENEFITS

Healthcare

Healthcare FSA

401(k)/
Retirement Plans

Employer Matching

Tuition Reimbursement

Paid Time Off

Location

Collaborative Culture

Competitive Compensation

Awards &
Recognition

Working in

Tempe Headquarters

Take a look at the map to see what's nearby.

Don’t miss out

Receive customized job alerts based on your function and/or location search criteria.

Interested inSelect a job category from the list of options. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

Join our talent pool

Upload your resume to help our recruiters match you to the right job. They'll be in touch if they find a good fit.

BD Fraud Notice

Please be aware of potentially fraudulent job postings on other websites or suspicious recruiting email or text messages that attempt to collect your confidential information. If you are concerned that an offer of employment with BD, CareFusion or C.R. Bard might be a scam, please verify by searching for the posting on the careers page or contact us at ASC.Americas@bd.com. For more information click here.