International Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist
2 weeks ago
Description
What will be your activities at bioMérieux?
The Regulatory Affairs Market team is looking for a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist to support Latin America & Canada region in a dynamic regulatory context.
The Regulatory Affairs Market team composed of 9 people is in daily contact with the local regulatory teams (subsidiaries and distributors) in order to guarantee the regulatory compliance of the products (reagents, instruments and software) for EME-AFRICA-ASPAC-LATAM region.
Reporting to the Regulatory Affairs Market Manager, your main responsibilities will be:
Be the privileged point of contact point with subsidiaries and distributors. Lead regular follow-ups with the countries (progress of files, new regulations, etc.) and work closely with LATAM Regional RA and other Global functions.
Responsible of Regulatory activities for a range of products :
Contribute to the development of the regulatory strategy
Coordinate and prepare the registration and renewal dossier within the defined deadlines in order to send it to the local regulatory contact.
Ensure the traceability of these shipments in the regulatory database and ensure reporting.
Follow-up of regulatory activities until approvals
Responsible for the regulatory watch of a group of countries in order to identify any change having an impact on the product development and/ or leading to new regulatory activities
Contribute to different working groups for transversal projects
Position Requirements:
- Bachelor's Degree in a scientific discipline -Regulatory Affairs Specialist: 1+ years of professional experience in regulatory affairs, either in medical devices or in a "Region" position.
-Senior Regulatory Affairs Specialist: 3+ years of professional experience in regulatory affairs, either in medical devices or in a "Region" position.
You have a professional level of spoken and written for both English and Spanish. You have high level of organization in your work, are detail oriented with good communication skills. You are also able to change easily your priorities and work on many subjects at the same time.
The level you qualify for will be determined in the interview process
#J-18808-Ljbffr
-
Hazelwood, United States Biomerieux Sa Full timeDescriptionWhat will be your activities at bioMerieux?The Regulatory Affairs Market team is looking for a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist to support Latin America & Canada region in a dynamic regulatory context.The Regulatory Affairs Market team composed of 9 people is in daily contact with the local regulatory teams...
-
Senior Contract Administration Specialist
3 days ago
Hazelwood, United States The Boeing Company Full timeAssesses process risks and control adequacy. Leads coordination and partnership with other internal functional disciplines. Leads coordination of special requests for approval and exception/interpretation of contractual matters. Performs due diligenc Contract, Specialist, Business Operations, Contracts, Senior, Technology, Business Services, Education
-
Senior Manager, Microbiology
1 week ago
Hazelwood, United States bioMérieux SA Full timeG lobal Medical Affairs Sr. Manager -Microbiology The Senior Manager of Global Medical Affairs leads the Peri /Post-commercial Launch Studies (PPLS) program , and the team dedicated to generating medical value and Health Economics and Outcome Research (HEOR) evidence of bioMérieux microbiology products ( antimicrobial susceptibility testing, organism...
-
Hazelwood, United States The Boeing Company Full timeExecute Request for Proposal/ Proposal Plan of Action (RFP/ PPOA) review, proposal pricing and development, order review, and interfacing with internal/external customers (e.g. Engineering, Procurement Financial Analysis, Financial Planning, Scheduli Contract, Specialist, Contracts, Financial Planning, Technology, Business Services, Business
-
Imaging Specialist I
6 days ago
Hazelwood, United States Iron Mountain Full timeAt Iron Mountain we know that work, when done well, makes a positive impact for our customers, our employees, and our planet. That's why we need smart, committed people to join us. Whether you're looking to start your career or make a change, talk to us and see how you can elevate the power of your work at Iron Mountain. We provide expert, sustainable...
-
Lab IT Technical Support Specialist
5 days ago
Hazelwood, United States BioFire Diagnostics Full timePosition Summary Provide high-level technical expertise, leadership, and direction through training, troubleshooting, and project management to internal and external customers for the diagnostic test systems marketed by bioMerieux. Items under the IT & Data Solutions umbrella include but are not limited to: LIS interfaces, networking, middleware solutions,...
-
Quality Specialist
3 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Position Summary:The Quality Inspection Specialist is responsible for performing physical inspection of card batches on the production floor, supports quality walkthroughs of production areas and changeovers between batches (as applicable). Initial schedule will be Wednesday through Saturday with a transition to another day shift schedule in...
-
Shredding Specialist
6 days ago
Hazelwood, Missouri, United States Stericycle Full timeWarehouse Specialist Needed12p - 8:30p, Mon - FriPay is: $16.78/hr + overtimeAbout Us:Stericycle is a U.S. based business-to-business services company and leading provider of compliance-based solutions that protects people and brands, promotes health and well-being, and safeguards the environment. Since our founding over 30 years ago, we have grown from a...
-
Warehouse Specialist
5 days ago
Hazelwood, United States Stericycle Full timeAbout Us: Stericycle is a U.S. based business-to-business services company and leading provider of compliance-based solutions that protects people and brands, promotes health and well-being, and safeguards the environment. Since our founding over 30 years ago, we have grown from a small start-up in medical waste management into a leader across a range of...
-
Warehouse Specialist
6 days ago
Hazelwood, Missouri, United States Stericycle Full timeAbout Us:Stericycle is a U.S. based business-to-business services company and leading provider of compliance-based solutions that protects people and brands, promotes health and well-being, and safeguards the environment. Since our founding over 30 years ago, we have grown from a small start-up in medical waste management into a leader across a range of...
-
Senior Software Engineer
2 weeks ago
Hazelwood, United States BioFire Diagnostics Full timeSenior Software Support Engineer Description: The Senior Software Support Engineer will support and develop software for internal R&D departments that are responsible for creating innovative IVD solutions. Collaborate with leads from other disciplines (embedded software, microbiology, biomathematics, etc.) to provide outstanding application support...
-
Sr. Internal Auditor
6 days ago
Hazelwood, United States Bunzl plc Full timeAt Bunzl, we believe that our people are central to our success and so developing them is a priority for our business. Our purpose is to deliver essential business solutions around the world and create long-term sustainable value for the benefit of all our stakeholders. Position Summary: The Senior Auditor is primarily based in St Louis MO and will be...
-
Warehouse Specialist
6 days ago
Hazelwood, Missouri, United States Stericycle Full timeAbout Us:Schedule: Monday-Friday 12:00pm-8:30pmPay: $16.78 per hour Stericycle is a U.S. based business-to-business services company and leading provider of compliance-based solutions that protects people and brands, promotes health and well-being, and safeguards the environment. Since our founding over 30 years ago, we have grown from a small start-up in...
-
Sr. Internal Auditor
4 hours ago
Hazelwood, United States Bunzl Full timeAt Bunzl, we believe that our people are central to our success and so developing them is a priority for our business. Our purpose is to deliver essential business solutions around the world and create long-term sustainable value for the benefit of all our stakeholders. Position Summary: The Senior Auditor is primarily based in St Louis MO and will be...
-
Project Management Specialist 4
1 day ago
Hazelwood, United States Spectraforce Technologies Full timeJob Title: Project Management Specialist 4 Duration: 6 months Location: Hybrid - 3 days on-site required in St. Louis, MO Shift Timings: 7:00 AM - 3:30 PMResponsibilities: Leads, develops, coordinates, integrates, analyzes, and maintains integrated plans and schedules for complex projects, programs, and change-driven activities in accordance with the...
-
Senior Software Engineer
3 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Senior Software Support Engineer Description: The Senior Software Support Engineer will support and develop software for internal R&D departments that are responsible for creating innovative IVD solutions. Collaborate with leads from other disciplines (embedded software, microbiology, biomathematics, etc.) to provide outstanding application...
-
Support Logistics Systems Specialist
2 weeks ago
Hazelwood, United States The Boeing Company Full timeEvaluates customer requirements and develops support concepts for multiple products, including mission planning support tools, support documents, and other deliverable elements. Drafts, coordinates, and updates comprehensive system documentation, pla Support, Systems, Specialist, Logistics, Technical Writer, Technology
-
Sr. Internal Auditor
7 days ago
Hazelwood, United States Bunzl Full time**Description** At Bunzl, we believe that our people are central to our success and so developing them is a priority for our business. Our purpose is to deliver essential business solutions around the world and create long-term sustainable value for the benefit of all our stakeholders. **Position Summary:** The Senior Auditor is primarily based in St Louis...
-
Hazelwood, United States BioFire Diagnostics Full timeSenior Software Support Engineer Description: The Senior Software Support Engineer will support and develop software for internal R&D departments that are responsible for creating innovative IVD solutions. + Collaborate with leads from other disciplines (embedded software, microbiology, biomathematics, etc.) to provide outstanding application support (...
-
Hazelwood, United States BioFire Diagnostics Full timeSenior Software Support Engineer Description: The Senior Software Support Engineer will support and develop software for internal R&D departments that are responsible for creating innovative IVD solutions. Collaborate with leads from other disciplines (embedded software, microbiology, biomathematics, etc.) to provide outstanding application support (...