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BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Tempe, Arizona

Job Description Summary

Job Description

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 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.

Job Duties

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

2.2+ years in Regulatory Affairs, product registration, compliance, or quality systems preferred. Experience with European Medical Device Regulations is preferred.

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 PeripheralVascular’scompliance 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 PeripheralVascular’snotified body.

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

Education and/or Experience

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

2. Global regulatory submission experience is required. US regulatory submission experience is 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

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.

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Primary Work LocationUSA AZ - Tempe Headquarters

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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