Staff Regulatory Affairs Specialist Advertising/Labeling (hybrid)

BD; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Staff Regulatory Affairs Specialist to support Medication Management Solutions. This role involves navigating complex regulatory landscapes for medical devices and associated software on a global scale. You will engage in international labeling remediation, new product development, and compliance with both US and international regulations. If you have a passion for regulatory affairs and a desire to make a meaningful impact in the healthcare sector, this opportunity will allow you to thrive in a supportive environment that values growth and innovation.

Qualifications

• 5+ years of experience in Regulatory Affairs in the medical device/pharmaceutical industry.
• Bachelor's degree required; advanced degree preferred.

Responsibilities

• Support regulatory compliance with US and international regulations.
• Drive continuous improvement in internal processes and customer satisfaction.
• Assist in preparing and publishing registration documentation.

Skills

Strong prioritizing skills

Interpersonal skills

Communication skills

Analytical skills

Knowledge of global Regulatory Affairs

Familiarity with advertising and labeling

Education

Bachelor's degree in Life Sciences or Engineering

Advanced degree (e.g., MS in Life Sciences)

Job description

Job Description Summary

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.

Job Overview

As a Staff Regulatory Affairs Specialist in Advertising/Labeling, you will play a crucial role in supporting Medication Management Solutions (MMS) Dispensing products, including Medical Devices, Non-Medical Devices, associated Software, and Accessories on a global scale. Your primary responsibilities will involve international labeling remediation, new product development, sustaining, and end-of-life activities from a Regulatory Affairs perspective.

Responsibilities

1. Support regulatory efforts to comply with new and existing US and international regulations and directives (e.g., FDA Medical Device Regulations, EU Low Voltage Directive, EU Electromagnetic Compatibility Directive, etc.).
2. Problem-solve and escalate regulatory and compliance issues to senior management as necessary.
3. Drive continuous improvement in internal processes and customer satisfaction.
4. Support the monitoring and interpretation of current and new regulatory requirements and international standards for the US and other regions.
5. Ensure QMS requirements are followed and executed consistently from a Regulatory Affairs perspective.
6. Support efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content.
7. Support regulatory impact assessments for change controls and other Regulatory Affairs/Quality Assurance items from a review and approval level.
8. Assist in preparing, auditing, editing, and publishing registration documentation as needed.
9. Support business export control (BEC) listing of products for global release per Regulatory Affairs requirements.
10. Review and approve labels, labeling, and promotional materials to ensure regulatory compliance.
11. Work closely and collaboratively with Marketing and project teams to develop, review, and substantiate product claims.
12. Assist in the collection of regulatory intelligence for projects related to US and international labeling remediation.
13. Effectively communicate regulatory strategies to stakeholders.
14. Perform gap analysis to support labeling projects and remediation activities.
15. Remain current on standards and regulations affecting advertising, promotion, and labeling, and communicate the impact cross-functionally.

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 and/or pharmaceutical industry.

Skills

1. Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects.
2. Knowledge of global Regulatory Affairs requirements, regulations, and standards.
3. Excellent interpersonal, communication, and analytical skills, and the ability to partner with cross-functional colleagues to identify regulatory innovations.
4. Familiarity with advertising, promotion, and labeling in the medical device industry is desired.

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.