Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
In BD Integrated Diagnostic Solutions – Specimen Management (BD IDS SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics allowing you to broaden your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is focused on providing the regulatory support for new product development projects and maintaining continued market access of our existing product portfolio. The ideal candidate will be energetic, possess a strong regulatory background and performs well independently and as part of a team.
The Staff Regulatory Affairs Specialist will work in BD Integrated Diagnostic Solutions – Specimen Management providing regulatory leadership to cross-functional project teams from early development to new product launches in various markets including the US, EU, and others. The incumbent will develop and execute regulatory strategies to support new 510(k) submissions, CE marking applications, and support our international regulatory team in further launch activities. The incumbent will also support product lifecycle management activities including assessment of the regulatory impact of product changes and line extensions. The ideal candidate will have medical device and in vitro diagnostic experience in the US and EU.
Our people make all the difference in our success. Join us in our mission to advance the world of health.
Remote Optional (Eastern time zone preferred)
**This position does not offer relocation assistance**
- Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, PMA, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.
- Assess necessity for submitting a 510(k) application for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
- Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
- Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
- Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to stakeholders.
- Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
- Lead regulatory efforts required to comply with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.
- Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
- Review clinical and human factors protocols/reports to assure collection of appropriate data for regulatory submissions and regulatory compliance. Engages with Medical Affairs in the development and approval of Clinical Evaluation Report) to assure the documents meet regulatory requirements.
- Ensures FDA device listings and facility registrations are maintained.
- Request FOI information and maintain FOI files in alignment with business strategies.
- Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
- Coordinate and respond to requests for product information, and questionnaires requested by customers.
- Represent BD in relevant external trade organizations and regulatory standards development as necessary to support BD’s continuous product development and compliance efforts.
- Remain current on regulations affecting BD products (EU MDR/IVDR, reclassification activities, etc.) and keep the relevant team and supervisors informed about potential impact.
- Identify ways to improve the efficiency of current work process and execute them.
- Carry out the above tasks with limited supervision.
- B.S. degree in a technical discipline (e.g., engineering, bioengineering, biology, chemistry). Advanced degree preferred.
- Minimum 5 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies or 3 years of experience with an advanced degree.
- Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
- Demonstrated success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE) to FDA and other global regulatory agencies.
- Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas.
- International product registration experience preferred.
Knowledge, Skills, and Abilities:
- Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
- Strong communication (written, oral) and project management skills.
- Able to handle multiple competing tasks with great attention to detail.
- Strong critical thinking skills.
- Able to work independently to achieve objectives on or before schedule .
- Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.
- Comprehensive 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.
- Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and IVD directive IVDD 98/79/EC. Knowledge of EU MDR and IVDR preferred.
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.
Primary Work LocationUSA NJ - Franklin Lakes
Work ShiftNA (United States of America)
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Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.
Staff Regulatory Affairs Specialist
I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job.
Global Regulatory Operations Labeling Specialist
I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on.
Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist