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
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.
This position is responsible for the development and implementation of product registration dossiers in support of Greater Asia applications.
The candidate will be expected to compose, review, and summarize product technical data that is required by regulatory agencies to demonstrate compliance with global regulations and standards.
The candidate will be expected to interface and communicate effectively with international business colleagues and regulatory authorities.
Knowledge of international regulatory affairs is preferred.
Duties and Responsibilities:
Ensures adequate documentation of BD PI’s compliance to worldwide regulations and standards.
Prepares and supports international submissions and international product releases in accordance with applicable SOPs.
Maintains regulatory affairs files.
Develops working relationships with key personnel at the business unit and representatives of international business centers as well as with ministries of health.
Participates in new product development teams, as required, to ensure the product is in compliance with all internal and external worldwide regulatory requirements. Reviews, documents, and supports a worldwide regulatory strategy in support of product development goals.
Education and Experience:
This position requires a Bachelor’s Degree in Engineering, or one of the Life Sciences, or similar education.
Experience in International Regulatory Affairs is preferred. 0-3 years experience in regulatory affairs or relevant field preferred.
Knowledge of a second language is a plus.
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 a plus.
Proven computer software skills (Windows Word, Excel, Powerpoint, Project, Outlook).
While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment.
Work may involve continuous computer use with repetitive motion to wrists, hands and fingers.
The employee is occasionally required to bend, lift, reach or stoop.
Employee must be able to wear personal protective equipment.
Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.
Upon request, the company may make reasonable accommodations.
The employee may be in an open cubicle environment and must be able to work in a team-oriented, fast-paced environment.
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 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.
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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.
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