Senior Specialist, Regulatory Affairs (Remote)

Job Description SummaryAs Sr. Specialist of Regulatory Affairs you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development, sustaining, and end of life activities. This role is fully remote.

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. 

Primary Responsibilities:

• Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)

• Problem solve and escalate regulatory and compliance issues to senior management as necessary

• Drive continuous improvement in internal processes and customer satisfaction

• Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW

• Support that QMS requirements are followed and executed consistently from RA perspective

• Support efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content

• Support regulatory impact assessments for change controls and other RA/QA items from a review and approve level

• Assist in preparing, auditing, editing, and publishing registration documentation as needed

• Support business export control (BEC) listing of product for release globally per RA requirements

• Support the review and approval of product labeling, promotional, and advertising materials as needed.

About You:

• Minimum bachelor’s degree in RA, QA, engineering, or other science-related discipline

• Advanced degree (e.g. MS, Life Sciences) preferred

• RAPS RAC certification preferred

• Minimum of 5 years of strong Regulatory Affairs/Compliance experience in medical devices

• Knowledge of global Regulatory Affairs requirements, regulations, and standards

• Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects

• Excellent interpersonal, communication, and analytical skills and able to partner with cross-functional colleagues to identify regulatory innovation

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Salary ranges have been implemented to reward …