Job Description Summary

Regulatory Affairs Coordinator II provides administrative support to the UCC Regulatory Affairs Team including as needed database management and support of regulatory affairs activities and registration process. This position is able to use good judgment in order to complete all tasks in a timely manner with attention to detail and accuracy. Able to act independently and evaluate unusual situations as necessary. Maintain confidentiality in all matters. Able to maintain a high level of organizational, administrative and business skills along with excellent communication and interpersonal skills.

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Responsibilities:

• Coordinate and administer the Regulatory Change Management process.  Evaluate each request to ensure appropriate for department, compile all requested information, and compile summaries of responses to various requests.

• Administrates systems for the regulatory team.

• Works with Regulatory Affairs Specialists to assist with preparation of regulatory affairs documentation utilized to support various registrations, STEDs, and Dossiers.

• Must manage volume of word processing and correspondence to complement the needs of Regulatory Affairs.  This includes memos, letters, status reports, certificates, FDA documents, position descriptions, presentations, overheads, etc.

• Responsible for ordering department supplies and purchase orders for the department

• Creates requisitions using the applicable systems

• Responsible for updating standard operating procedures (SOP), work instructions (WI), and policies as appropriate.

• Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.

• Coordinate and upload regulatory documentation to EDMS.

Qualifications

Education and Experience:

• High School diploma or equivalent experience in a regulated environment

• 1-3 Years Regulatory Affairs or Quality Assurance experience with medical technology companies

Knowledge, Skills, and Abilities:

• Proficient in using Microsoft Word, Access, Excel and Outlook.

• Strong communication and project management skills.

• Must be able to balance multiple tasks.

• Attention to details.

• Knowledge of Medical Device Quality Systems and Good Documentation Practices.

• Able to be Notary Public.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

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 Location

USA GA - Covington BMD

Additional Locations

Work Shift

US BD 1st Shift 830am-4pm (United States of America)