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Regulatory Affairs Specialist I (Hybrid) at BD
Covington, Georgia, USA - Full Time
Skills Needed
It, Ownership, Healthcare Industry, Creativity, Clinical Documentation, Confidentiality, Communication Skills
Qualification
BSc
Experience Required
Minimum 1 year(s)
ESL/ ML Teacher- HPMS at Pennsauken Public Schools
Pennsauken, NJ 08109, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Therapist - CAT at Gracepoint
Tampa, FL 33610, USA - Full Time
Skills Needed
Microsoft Applications, Children, Excel
Qualification
Graduate
Automation & Software Integration Engineer at Foundation Robotics Labs Inc
San Francisco, CA 94107, USA - Full Time
Skills Needed
Embedded Systems, Computer Engineering, Python, C++, Test Systems, Test Automation Tools, Automation, Version Control, Software Integration, Hil, Git, Robotics
Specialization
Electrical, Electrical Engineering, Engineering
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Counselor - Zaharis Elementary School 2025-2026 at Mesa Public School
Mesa, AZ 85201, USA - Full Time
Skills Needed
Program Planning, Demonstration, Case, Resume, Research, Time Management, Accountability, Instructional Practices, Models, Consultation, Adherence, Collaboration, Signs, Fafsa, Referrals, Crisis Situations, Crisis, Community Organizations, It, Program Development
Qualification
BA
Account Resourcer at Affinity Workforce
Bristol, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
WFH Recruitment Researcher (No Base Salary but High Commission) at KAIROS GLOBAL SEARCH PTE LTD
Singapore, Southeast, Singapore - Full Time
Skills Needed
Communication Skills, Analytical Skills, Databases
Qualification
Graduate
SAP Signavio iXp Intern (f/m/d) - Enterprise Vulnerability Management and D at SAP
6SLR, Baden-Württemberg, Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Injection Mold Tooling Technician at Tiercon
Hamilton, ON L8E 5N7, Canada - Full Time
Skills Needed
Good Communication Skills
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Junior HR Specialist at Il Mannarino
Monza, Lombardia, Italy - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Manager 2, Business Data Analytics at Intuit
San Diego, CA 92129, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Supply Chain- Strategic Sourcing Manager at Arrowhead Engineered Products
Remote, Oregon, USA - Full Time
Skills Needed
Access, Contract Management, Power Bi, Powerpoint, Management Skills, Excel, Sap, Leadership, Databases, Netsuite, Interpersonal Skills, Microsoft, Strategic Thinking
Specialization
Engineering, Management, Supply Chain Management
Qualification
BSc
Experience Required
Minimum 7 year(s)
Network Operations Engineer at Terralogic
San José, Provincia de San José, Costa Rica - Full Time
Skills Needed
Solarwinds, Network Automation, Security, Computer Science, Collaboration, English, Network Diagrams, Network Monitoring Tools, Training, Wireless, Communication Skills, Information Technology, Visio
Specialization
Computer science information technology or equivalent experience
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Georgia Pre K Teacher at The Nest Schools
Canton, GA 30115, USA - Full Time
Skills Needed
Early Childhood Education, Child Development, Kindergarten, Credit, Pre K
Qualification
Diploma
Experience Required
Minimum 4 year(s)
Front-Line Mechanical & Structural Engineering Manager at Boeing
Titusville, Florida, USA - Full Time
Skills Needed
Aerospace, Civil Engineering, Mentoring, Teams, Leadership Skills
Specialization
Engineering engineering technology (includes manufacturing engineering technology chemistry physics mathematics data science or computer science
Qualification
BSc
Experience Required
Minimum 5 year(s)
Elementary Principal at Johnston Community School District
Johnston, IA 50131, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
Administration
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Customer Service Representative - Eurofins BioPharma Product Testing Toront at Eurofins Canada BioPharma
Toronto, ON, Canada - Full Time
Skills Needed
Customer Service Skills, Computer Skills, Confidentiality, Productivity, Outlook, English, Disabilities, Resumes, Overtime, Disability Insurance, Excel, Filing, Communication Skills, Discretion
Qualification
Diploma
Experience Required
Minimum 3 year(s)
Entry Level Administrator: Risk at Absa Bank Limited
Sandton, Gauteng, South Africa - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Vice President, Data Platforms at CodaMetrix
Boston, Massachusetts, USA - Full Time
Skills Needed
Kafka, Ml, Dbt, Collaboration, Computer Science, Data Architecture, Licensure, Data Security, Communication Skills, Azure, Hitrust, Spark, Data Engineering, Hipaa, Aws, Market Data, Information Systems
Specialization
Computer Science, Engineering, Information Systems
Qualification
Graduate
.Net Fullstack Developer at Marktine Technology Solutions
San Francisco, CA 94102, USA - Full Time
Skills Needed
Microservices, Front End Development, Python, Containerization
Qualification
Graduate
Regulatory Affairs Specialist I (Hybrid) at BD
Covington, Georgia, USA -
Full Time


Start Date

Immediate

Expiry Date

11 Jul, 25

Salary

0.0

Posted On

11 Apr, 25

Experience

1 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

It, Ownership, Healthcare Industry, Creativity, Clinical Documentation, Confidentiality, Communication Skills

Industry

Pharmaceuticals

Description

JOB DESCRIPTION SUMMARY

Regulatory Affairs Specialist I, Hybrid - in office 4 days (Covington, GA)
Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.

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.

EDUCATION AND EXPERIENCE REQUIRED:

  • BS in a scientific field with 1+ years employment in the areas of medical device product registration, compliance or quality systems; or Combination of education and experience determined to be equivalent
  • Regulatory Affairs Certification (RAC) desired
  • Knowledge of the U.S. and European medical device regulations preferred
  • Maintain confidentiality in dealing with regulatory and clinical documentation
  • Excellent written and verbal communication skills
  • Self-motivated by working independently and having the ability to take ownership of their responsibilities
  • Must be able to prioritize and handle several projects concurrently
  • Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
    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.
Responsibilities
  • Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
  • Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required
  • Provide technical collaborate with FDA and international reviewers and respond to questions
  • Provide timely review and approval of product labeling and marketing claims for regulatory compliance
  • Provide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
Regulatory Affairs Specialist I (Hybrid) at BD
Covington, Georgia, USA - Full Time
Skills Needed
It, Ownership, Healthcare Industry, Creativity, Clinical Documentation, Confidentiality, Communication Skills
Qualification
BSc
Experience Required
Minimum 1 year(s)
ESL/ ML Teacher- HPMS at Pennsauken Public Schools
Pennsauken, NJ 08109, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Therapist - CAT at Gracepoint
Tampa, FL 33610, USA - Full Time
Skills Needed
Microsoft Applications, Children, Excel
Qualification
Graduate
Automation & Software Integration Engineer at Foundation Robotics Labs Inc
San Francisco, CA 94107, USA - Full Time
Skills Needed
Embedded Systems, Computer Engineering, Python, C++, Test Systems, Test Automation Tools, Automation, Version Control, Software Integration, Hil, Git, Robotics
Specialization
Electrical, Electrical Engineering, Engineering
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Counselor - Zaharis Elementary School 2025-2026 at Mesa Public School
Mesa, AZ 85201, USA - Full Time
Skills Needed
Program Planning, Demonstration, Case, Resume, Research, Time Management, Accountability, Instructional Practices, Models, Consultation, Adherence, Collaboration, Signs, Fafsa, Referrals, Crisis Situations, Crisis, Community Organizations, It, Program Development
Qualification
BA
Account Resourcer at Affinity Workforce
Bristol, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
WFH Recruitment Researcher (No Base Salary but High Commission) at KAIROS GLOBAL SEARCH PTE LTD
Singapore, Southeast, Singapore - Full Time
Skills Needed
Communication Skills, Analytical Skills, Databases
Qualification
Graduate
SAP Signavio iXp Intern (f/m/d) - Enterprise Vulnerability Management and D at SAP
6SLR, Baden-Württemberg, Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Injection Mold Tooling Technician at Tiercon
Hamilton, ON L8E 5N7, Canada - Full Time
Skills Needed
Good Communication Skills
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Junior HR Specialist at Il Mannarino
Monza, Lombardia, Italy - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Manager 2, Business Data Analytics at Intuit
San Diego, CA 92129, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Supply Chain- Strategic Sourcing Manager at Arrowhead Engineered Products
Remote, Oregon, USA - Full Time
Skills Needed
Access, Contract Management, Power Bi, Powerpoint, Management Skills, Excel, Sap, Leadership, Databases, Netsuite, Interpersonal Skills, Microsoft, Strategic Thinking
Specialization
Engineering, Management, Supply Chain Management
Qualification
BSc
Experience Required
Minimum 7 year(s)
Network Operations Engineer at Terralogic
San José, Provincia de San José, Costa Rica - Full Time
Skills Needed
Solarwinds, Network Automation, Security, Computer Science, Collaboration, English, Network Diagrams, Network Monitoring Tools, Training, Wireless, Communication Skills, Information Technology, Visio
Specialization
Computer science information technology or equivalent experience
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Georgia Pre K Teacher at The Nest Schools
Canton, GA 30115, USA - Full Time
Skills Needed
Early Childhood Education, Child Development, Kindergarten, Credit, Pre K
Qualification
Diploma
Experience Required
Minimum 4 year(s)
Front-Line Mechanical & Structural Engineering Manager at Boeing
Titusville, Florida, USA - Full Time
Skills Needed
Aerospace, Civil Engineering, Mentoring, Teams, Leadership Skills
Specialization
Engineering engineering technology (includes manufacturing engineering technology chemistry physics mathematics data science or computer science
Qualification
BSc
Experience Required
Minimum 5 year(s)
Elementary Principal at Johnston Community School District
Johnston, IA 50131, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
Administration
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Customer Service Representative - Eurofins BioPharma Product Testing Toront at Eurofins Canada BioPharma
Toronto, ON, Canada - Full Time
Skills Needed
Customer Service Skills, Computer Skills, Confidentiality, Productivity, Outlook, English, Disabilities, Resumes, Overtime, Disability Insurance, Excel, Filing, Communication Skills, Discretion
Qualification
Diploma
Experience Required
Minimum 3 year(s)
Entry Level Administrator: Risk at Absa Bank Limited
Sandton, Gauteng, South Africa - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Vice President, Data Platforms at CodaMetrix
Boston, Massachusetts, USA - Full Time
Skills Needed
Kafka, Ml, Dbt, Collaboration, Computer Science, Data Architecture, Licensure, Data Security, Communication Skills, Azure, Hitrust, Spark, Data Engineering, Hipaa, Aws, Market Data, Information Systems
Specialization
Computer Science, Engineering, Information Systems
Qualification
Graduate
.Net Fullstack Developer at Marktine Technology Solutions
San Francisco, CA 94102, USA - Full Time
Skills Needed
Microservices, Front End Development, Python, Containerization
Qualification
Graduate
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