BD
Staff Regulatory Affairs Specialist - Becton Dickinson
BD, San Diego, California, United States, 92189
Staff Regulatory Affairs Specialist - Becton Dickinson
Join to apply for the
Staff Regulatory Affairs Specialist - Becton Dickinson
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BD Staff Regulatory Affairs Specialist - Becton Dickinson
1 day ago Be among the first 25 applicants Join to apply for the
Staff Regulatory Affairs Specialist - Becton Dickinson
role at
BD Get AI-powered advice on this job and more exclusive features. 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. Job Description Summary
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.
Job Overview
As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management Solutions (MMS) dispensing products, including non-medical devices, medical devices, associated software, and accessories on a global scale.
Responsibilities
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.). 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 interpretation of current and new regulatory requirements and international standards for the US and other regions. Ensure QMS requirements are followed and executed consistently from a Regulatory Affairs 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 Regulatory Affairs/Quality Assurance items from a review and approval level. Assist in preparing, auditing, editing, and publishing registration documentation as needed. Support business export control (BEC) listing of products for global release per Regulatory Affairs requirements. Review and approve labels, labeling, and promotional materials to ensure regulatory compliance. Assist in the collection of regulatory intelligence for projects related to US and international labeling remediation. Perform gap analysis to support labeling projects and remediation activities. 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 industry required Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects required Knowledge of global Regulatory Affairs requirements, regulations, and standards strongly preferred Demonstrated ability to partner with cross-functional colleagues to identify regulatory innovations required Familiarity with advertising, promotion, and labeling in the medical device industry is desired
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/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.
#CLOLI
Required Skills
Optional Skills
Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
Work Shift
At 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 or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$124,700.00 - $205,800.00 USD AnnualPandoLogic. Keywords: Regulatory Compliance Specialist, Location: San Diego, CA - 92108
Seniority level
Seniority level
Not Applicable Employment type
Employment type
Full-time Job function
Job function
Legal Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at BD by 2x Get notified about new Regulatory Affairs Specialist jobs in
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San Diego Metropolitan Area $55.00-$65.00 6 days ago Manager/ Sr. Manager, Regulatory Affairs
Associate Director, Regulatory Affairs CMC
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Join to apply for the
Staff Regulatory Affairs Specialist - Becton Dickinson
role at
BD Staff Regulatory Affairs Specialist - Becton Dickinson
1 day ago Be among the first 25 applicants Join to apply for the
Staff Regulatory Affairs Specialist - Becton Dickinson
role at
BD Get AI-powered advice on this job and more exclusive features. 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. Job Description Summary
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.
Job Overview
As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management Solutions (MMS) dispensing products, including non-medical devices, medical devices, associated software, and accessories on a global scale.
Responsibilities
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.). 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 interpretation of current and new regulatory requirements and international standards for the US and other regions. Ensure QMS requirements are followed and executed consistently from a Regulatory Affairs 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 Regulatory Affairs/Quality Assurance items from a review and approval level. Assist in preparing, auditing, editing, and publishing registration documentation as needed. Support business export control (BEC) listing of products for global release per Regulatory Affairs requirements. Review and approve labels, labeling, and promotional materials to ensure regulatory compliance. Assist in the collection of regulatory intelligence for projects related to US and international labeling remediation. Perform gap analysis to support labeling projects and remediation activities. 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 industry required Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects required Knowledge of global Regulatory Affairs requirements, regulations, and standards strongly preferred Demonstrated ability to partner with cross-functional colleagues to identify regulatory innovations required Familiarity with advertising, promotion, and labeling in the medical device industry is desired
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/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.
#CLOLI
Required Skills
Optional Skills
Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
Work Shift
At 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 or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$124,700.00 - $205,800.00 USD AnnualPandoLogic. Keywords: Regulatory Compliance Specialist, Location: San Diego, CA - 92108
Seniority level
Seniority level
Not Applicable Employment type
Employment type
Full-time Job function
Job function
Legal Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at BD by 2x Get notified about new Regulatory Affairs Specialist jobs in
San Diego, CA . Quality Assurance Specialist (Compliance Specialist)
Associate Regulatory Affairs Manager (San Diego)
Staff Regulatory Affairs Specialist, Software - Becton Dickinson
Staff Specialist Regulatory Affairs (Hybrid) - Becton Dickinson
Staff Regulatory Affairs Specialist, Software
Solana Beach, CA $115,000.00-$135,000.00 3 months ago Associate Director of Regulatory Affairs
Regulatory Affairs Associate Director or Senior Manager
Staff Specialist Regulatory Affairs (Hybrid)
Senior Regulatory Affairs Manager (Onsite)
Associate Director, Regulatory Affairs CMC
San Diego County, CA $140,000.00-$170,000.00 3 weeks ago Manager, Vendor Contracts & Regulatory Affairs
San Diego Metropolitan Area $55.00-$65.00 6 days ago Manager/ Sr. Manager, Regulatory Affairs
Associate Director, Regulatory Affairs CMC
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr