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 Description Summary
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.
Primary Work LocationUSA AZ - Tempe Headquarters
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.
- 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.
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.
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