Job Description Summary

The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Urology and Critical Care Business unit will work on regulatory strategy and submissions for urinary devices, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions required to market medical devices in both the U.S. and Europe. The Senior RA Specialist will also support related regulatory affairs activities, such as development, execution and management of procedures and systems to ensure that the product development process addresses all regulatory requirements and objectives of the business. The incumbent should have proven leadership and success working in cross-functional teams and will perform crucial duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates.

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.

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. 

The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Urology and Critical Care Business unit will work on regulatory strategy and submissions for urinary devices, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions required to market medical devices in both the U.S. and Europe. The Senior RA Specialist will also support related regulatory affairs activities, such as development, execution and management of procedures and systems to ensure that the product development process addresses all regulatory requirements and objectives of the business. The incumbent should have proven leadership and success working in cross-functional teams and will perform crucial duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates.

Responsibilities:

• Regulatory support through the product life cycle and a core team member on project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents).

• Represents RA and demonstrates leadership in product development team(s). Responsible for completion of regulatory strategies, review and approval of design control-related documents.

• Lead cross functional team in preparing and implementing submissions to the US FDA with a focus on Class II products. Act as liaison with FDA regarding product submissions.

• Lead cross functional team in preparing and implementing technical files for submission to European Notified Bodies. Act as liaison with Notified Bodies regarding product submissions.

• Assess necessity for reporting changes to FDA for device modifications. Prepare robust justifications for changes that do not require notices. Address and resolve requests for additional information.

• Identify and communicate appropriately quantified risks and mitigations associated with regulatory strategies to cross-functional team members.

• Lead development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register devices worldwide.

• Provide cross-functional support for regulatory submissions and compliance, including approval of product labeling; review of clinical and human factors protocols; and writing/updating standard operating procedures, work instructions, and policies.

Required Education and Experience:

• Bachelor of Science required, preferably in a Scientific Field or Regulated Industry

• Minimum 5 years experience in Regulatory or Quality (including experience with medical devices); experience in areas of product registration, compliance or quality systems

Required Knowledge, Skills, And Abilities

• Must demonstrate ability to provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control assessments, timeline development, and reviewing submission related documents).

• Author and support 510(k), Tech File / STED File submissions as required.

• Update STED technical files for CE marking activities and notified body interaction to maintain EU/MDR product registrations.

• Must be able to maintain confidentiality in dealing with regulatory and clinical documentation

• Must be self-motivated by working independently and having the ability to take ownership of their responsibilities.

• Must have knowledge of the U.S. and European medical device regulations.

• Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience.

• Proficient in using Microsoft Word, Excel, PowerPoint, and Project.

• Strong communication (written, oral) and project management skills.

• Ability to balance multiple tasks with attention to detail with limited supervision.

• Demonstrated global perspective, cross-functional teamwork and partnership skills.

• Knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.

• Limited travel required – 15%.

Preferred Qualifications:

• Regulatory Affairs Certification (RAC) preferred.

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.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift