Job Description Summary

Job Description

This position will provide Regulatory Affairs (RA) support for new product development projects, sustaining of legacy products, process and systems remediation projects, and the preparation of regulatory submissions required to legally market medical devices in the US under 510K/PMA, and in the European Union under the MDR. This role will provide support for global product registrations and related regulatory affairs activities, as required. This role will appropriately execute project activities based on applicable products and systems which are designed to ensure that the product development process adheres to all regulatory requirements as well as objectives to the business. The candidate is expected to utilize project planning skills to initiate, plan, and execute regulatory projects and submissions with support of supervisor. The candidate must be able to manage change and be flexible when providing solutions. The candidate will be expected to collaborate with their regulatory team, cross functional team members, and regulatory agency partners by building strong and effective working relationships.

This position includes benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy. This position will support BD integration efforts.

EDUCATION AND/OR EXPERIENCE

• Bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering or medical-related field. 
• A minimum of 2+ years in Regulatory Affairs, product registration, compliance, or quality systems preferred.
• Experience with European Medical Device Regulations is preferred.
• 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: BDPI 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.

ESSENTIAL JOB FUNCTIONS

• Understands and has working knowledge of US 510K/PMA Regulations, and European Medical Device Regulations.  Supports international product submissions/registrations, as needed.
• 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 remediation goals.
• Initiates and updates regulatory registrations as required and per applicable SOPs.
• Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards.
• Provides general support for regulatory team and special projects, as needed.
• Assists in the preparation of division procedures to ensure compliance with US 510K/PMA, EU MDR, and other Regulatory and Corporate requirements.
• Ensures adequate documentation of BDPI’s compliance to FDA, European and global regulations and standards.  Ensures maintenance of regulatory documentation.

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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