BD
Senior Regulatory Affairs Specialist (hybrid)
BD, Franklin Lakes, New Jersey, us, 07417
Job Description SummaryJob DescriptionWe 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.
In BD – Specimen Management (BD 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 Senior Regulatory Affairs Specialist position is primarily focused on maintaining continued market access of our existing product portfolio, in addition to opportunities to provide regulatory support for new product development projects. The ideal candidate will be energetic, possess a strong regulatory background and perform well independently and as part of a team.
Job Overview:
The Senior Regulatory Affairs Specialist will work in BD – 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 support product lifecycle management activities for Lab Specimen Management products, including assessments of the regulatory impact of product changes and line extensions. The incumbent may also 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 ideal candidate will have medical device and in vitro diagnostic experience in the US and EU, as well as experience with project management activities.
Education and Experience:
B.S. degree in a technical discipline (e.g., engineering, bioengineering, biology, chemistry) or project management.
Minimum 3 years Regulatory Affairs and/or Project Management experience in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree.
Demonstrated ability to lead a cross-functional team to consistently meet project timelines.
Knowledge and Skills:
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.
Able to work independently to achieve objectives on or before schedule.
Demonstrated cross-functional collaboration and teamwork skills including influencing without authority.
Comprehensive knowledge of medical device regulations and standards.
Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred.
Ability to navigate ambiguous regulatory requirements and standards interpretation.
This is a hybrid position where the candidate is required to be in the office a minimum of 3 days a week. Office location is either Franklin Lakes, NJ or Sparks, MD.
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.
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA MD - Sparks - 7 Loveton Circle
Work ShiftAt BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary Range Information:
$103,500.00 - $170,800.00 USD Annual
#J-18808-Ljbffr
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.
In BD – Specimen Management (BD 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 Senior Regulatory Affairs Specialist position is primarily focused on maintaining continued market access of our existing product portfolio, in addition to opportunities to provide regulatory support for new product development projects. The ideal candidate will be energetic, possess a strong regulatory background and perform well independently and as part of a team.
Job Overview:
The Senior Regulatory Affairs Specialist will work in BD – 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 support product lifecycle management activities for Lab Specimen Management products, including assessments of the regulatory impact of product changes and line extensions. The incumbent may also 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 ideal candidate will have medical device and in vitro diagnostic experience in the US and EU, as well as experience with project management activities.
Education and Experience:
B.S. degree in a technical discipline (e.g., engineering, bioengineering, biology, chemistry) or project management.
Minimum 3 years Regulatory Affairs and/or Project Management experience in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree.
Demonstrated ability to lead a cross-functional team to consistently meet project timelines.
Knowledge and Skills:
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.
Able to work independently to achieve objectives on or before schedule.
Demonstrated cross-functional collaboration and teamwork skills including influencing without authority.
Comprehensive knowledge of medical device regulations and standards.
Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred.
Ability to navigate ambiguous regulatory requirements and standards interpretation.
This is a hybrid position where the candidate is required to be in the office a minimum of 3 days a week. Office location is either Franklin Lakes, NJ or Sparks, MD.
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.
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA MD - Sparks - 7 Loveton Circle
Work ShiftAt BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary Range Information:
$103,500.00 - $170,800.00 USD Annual
#J-18808-Ljbffr