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.

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