International Regulatory Affairs Specialist
3 weeks ago
Description
What will be your activities at bioMrieux?
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.
-The ability to speak and write in both Spanish and English is required.
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.
#J-18808-Ljbffr
-
Hazelwood, United States HonorVet Technologies Full timeRA Specialist Life Cycle Management Candidates need to have proven basic Excel skills. This role uses Excel heavily. Rapid learners, great note takers, motivated detailed oriented candidates! Specific Missions The Corporate Regulatory Affairs LCM (Life Cycle Management) department is looking for a Regulatory Affairs Specialist in a dynamic regulatory...
-
Lab IT Technical Support Specialist
2 weeks 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,...
-
Laboratory IT Software Specialist I
4 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Provide Data & IT technical support, training, troubleshooting, and project management to internal and external customers for the diagnostic test systems marketed by bioMrieux. Items under the IT & Data solutions umbrella include but are not limited to: LIS interfaces, networking, Torch/SPOTFIRE, VITEK Reveal, middleware solutions, data...
-
Quality Specialist
6 days 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...
-
Quality Specialist On Floor Support Quailty Ops
4 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription 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 Utilize AQL sampling guidance to inspect cards, pouches, and cartons for physical anomalies or rejects.May support containment of rejected...
-
6G5DI4-Structural Analysis Engineer 4
3 days ago
Hazelwood, United States Indotronix International Corporation Full timeIndotronix is seeking a Onsite Job -Structural Analysis Engineer 4 for a Job Opportunity in Hazelwood,Missouri. Clearance Required : No Position comments: 100% on site. Secret clearance post start. Job Description : Leads development, integration and documentation of structural requirements to establish the system design. Coordinates with other engineering...
-
Sr Supplier Quality Engineer
4 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Position SummaryEnsure products and services received from suppliers meet the quality standards of bioMerieux. Work closely with Suppliers, Global Purchasing, Supply Chain, Industrialization, Manufacturing and Engineering in the execution of the supplier quality program. Provide quality support in the areas of SCAR management, supplier change...
-
Sr Supplier Quality Engineer
3 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Position Summary Ensure products and services received from suppliers meet the quality standards of bioMerieux. Work closely with Suppliers, Global Purchasing, Supply Chain, Industrialization, Manufacturing and Engineering in the execution of the supplier quality program. Provide quality support in the areas of SCAR management, supplier change...
-
Marketing Specialist
3 weeks ago
Hazelwood, Missouri, United States Dynamic Transit Co. Full timeBrand awareness. Engagement. Talent attraction. Visual storytelling. Data analysis.You love understanding what motivates people and playing with new and creative ways to attract them. Bringing a company's brand to life gets you excited as does working for a small company who values collaboration, inspiration, and execution.When you join the Recruiting &...
-
Inbound/Outbound Specialist
3 weeks ago
Hazelwood, United States Expeditors Full timeJob DescriptionJob DescriptionCompany Description“We’re not in the shipping business; we’re in the information business” -Peter Rose, Expeditors FounderGlobal supply chain management is what we do, but at the heart of Expeditors you will find professionalism, leadership, and a friendly environment, all of which foster an innovative, customer...
-
Mechanical Engineer
2 weeks ago
Hazelwood, United States BioFire Diagnostics Full timePosition Summary: Support and sustain Instrument Manufacturing activities and facilitate efficient operations within the production environment, optimize existing processes and ensure established production goals are achieved. Collaborates with engineers and technicians to ensure the successful design, development, testing and implementation of both product...
-
Mechanical Engineer
2 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Position Summary:Support and sustain Instrument Manufacturing activities and facilitate efficient operations within the production environment, optimize existing processes and ensure established production goals are achieved. Collaborates with engineers and technicians to ensure the successful design, development, testing and implementation of...
-
Mechanical Engineer
4 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Position Summary:Support and sustain Instrument Manufacturing activities and facilitate efficient operations within the production environment, optimize existing processes and ensure established production goals are achieved. Collaborates with engineers and technicians to ensure the successful design, development, testing and implementation of...
-
Mechanical Engineer
4 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Position Summary:Support and sustain Instrument Manufacturing activities and facilitate efficient operations within the production environment, optimize existing processes and ensure established production goals are achieved. Collaborates with engineers and technicians to ensure the successful design, development, testing and implementation of...
-
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 (...
-
Associate Principal Mechanical Engineer
1 week ago
Hazelwood, United States BioFire Diagnostics Full timePosition Summary: Support and sustain Instrument Manufacturing activities to facilitate efficient operations within the production environment, optimize existing processes and ensure established production goals are achieved. Mentor and lead engineers and technicians to ensure the successful design, development, testing and implementation of both product...
-
Senior Software Engineer
7 hours 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...
-
Associate Principal Mechanical Engineer
3 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Position Summary:Support and sustain Instrument Manufacturing activities to facilitate efficient operations within the production environment, optimize existing processes and ensure established production goals are achieved. Mentor and lead engineers and technicians to ensure the successful design, development, testing and implementation of both...
-
Associate Principal Mechanical Engineer
3 weeks ago
Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Position Summary: Support and sustain Instrument Manufacturing activities to facilitate efficient operations within the production environment, optimize existing processes and ensure established production goals are achieved. Mentor and lead engineers and technicians to ensure the successful design, development, testing and implementation of...