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.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
Professional who reports to the E&C Manager Andean and South Cone and provides support to all E&C Managers allocated in LATAM hubs to provide support in day-to-day HCP/HCO interaction processes and to comply with a series of regional and global Compliance standards.Job Description
How about belonging a leading global medical technology company that acts advancing the world of health? 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.
Professional who reports to the E&C Manager Andean and South Cone and provides support to all E&C Managers allocated in LATAM hubs to provide support in day-to-day HCP/HCO interaction processes and to comply with a series of regional and global Compliance standards.
Essential / Key Responsibilities
Ethics and Compliance
- Analyze and provide feedback (approval/rejection) on interactions that BD has with HCPs/HCOs and GOs according to the ABAC Compliance program for LATAM.
- Support LATAM businesses in ABAC policies and processes.
- Monthly and quarterly monitoring and analysis of processes requested through Compliance platforms, such as Interactions Hub and Cybergrants.
- Preparation of reports detailing observations identified during the quarterly review, and sending reports to management.
Third Parties
- Review the TPI justification form.
- Initiate and review the Due Diligence process (DDPs) for all TPIs contracted by BD (e.g., Distributors, Resellers, Sales Agents, Consultants, among others).
- Assign FCPA training to all applicable TPIs.
- Approve the creation of TPIs in our accounting systems, such as SAP or NODUM.
- Monthly analysis of reports from Compliance, Master Data, and Finance to identify third parties that do not comply with our Global “Life Cycle Management” policy.
- Follow up on pending activities with stakeholders.
- Prepare the monthly Key Performance Indicators (KPIs) report with stakeholders.
Required Experience, Knowledge & Skills:
- University Degree (Auditor, Accountant, Business Engineer, Business Administration or similar)
- EXPERIENCE: 1 to 2 years in multinational companies.
- Basic English – desirable
- Portuguese – desirable
Professional Competencies (relevant skills for the position):
- Proactive
- Continuous and versatile learning
- Customer focus
- Active pursuit of results
- Process efficiency
- Promote an inclusive work environment
- Teamwork
- Sense of confidentiality
Required Skills
Optional Skills
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Primary Work Location
COL Cundinamarca - BogotaAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter