Staff Regulatory Affairs Specialist

Staff Regulatory Affairs Specialist

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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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.

Job Overview

As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management Solutions (MMS) dispensing products, including non-medical devices, medical devices, associated software, and accessories on a global scale.

Responsibilities

• Support regulatory efforts to comply with new and existing US and international regulations and directives.
• Problem-solve and escalate regulatory and compliance issues to senior management as necessary.
• Support the monitoring and interpretation of current and new regulatory requirements and international standards for the US and other regions.
• Support efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content.
• Assist in preparing, auditing, editing, and publishing registration documentation as needed.
• Review and approve labels, labeling, and promotional materials to ensure regulatory compliance.
• Perform gap analysis to support labeling projects and remediation activities.

Education

Bachelor's degree required with a focus in Life Sciences or Engineering preferred. An advanced degree (e.g., MS, Life Sciences) is preferred.

Certifications

RAPS RAC certification is preferred.

Experience

Minimum of five (5) years of Regulatory Affairs experience in the medical device industry required. Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects required. Knowledge of global Regulatory Affairs requirements, regulations, and standards strongly preferred. Demonstrated ability to partner with cross-functional colleagues to identify regulatory innovations required.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. 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.

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.

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.