6 empleos en Cdmx

Regulatory Affairs Specialist - Foránea

Ivemsa

BS/MS in Science with demonstrated in-depth understanding of those principles in a related field. 3-5 years experience in the regulatory field or regulated industry with FDA and applicable international regulations and standards, 4-7 years preferred. Regulatory Affairs Certification (RAC) desired Internal auditor certification Experience working on products that were developed and submitted for 510K. Experience in working effectively with cross-functional teams and provide regulatory input (e.g., manufacturing sites, new product development teams, marketing teams, quality teams). Must have proven ability to prepare and submit documents to regulatory agencies independently or with minimal supervision. Ability to explain regulatory requirements and pitfalls to project teams and colleagues. Willingness to take ownership and accept responsibility for actions and decisions. Regulatory submission experience with the EU MDR or MDD is required. Experience with MDD-MDR transition and PMS activities. Experience with assigning UDI ( Unique Device Identification) to products Audit experience preferable. (ISO, EU MDR, MDSAP) Demonstrates excellent written, oral, and interpersonal skills with personnel at all levels. Exhibits a high degree of integrity, initiative and motivation. Strong ethics and regulatory compliance awareness Attention to detail and ability to manage multiple tasks Capacity to work independently, with excellent time management and judgment in task prioritization Able to interact with multiple individuals in a positive, constructive manner and under a variety of circumstances. Ability to quickly and effectively build relationships, interact, and communicate information with internal and external stakeholders. Excellent English verbal and written communication skills Computer skills with proficiency in Microsoft Office (Word, Excel) and Adobe Acrobat Familiarity with ISO 14971 Risk Management. Understanding of design controls, DHF, and Gate Process life cycle

Hace 4 horas en Tijuana

Senior Manager Structural Engineering (Onsite) - Foránea

Collins Aerospace.

Qualifications You Must Have: Bachelor’s degree in engineering and a minimum of 7 years’ experience leading teams Background in structural or stress engineering analysis Proven track record in managing or guiding engineering teams Skilled in working closely with internal and external stakeholders or clients Knowledge of aircraft structural systems, components, and assemblies Strong grasp of load transfer principles and balancing; hands-on experience with classical analysis techniques Lean oriented with exposure to and application of process improvement methodologies Qualifications We Prefer: Ability to represent the company in technical review meetings and have excellent customer relations Proven successful leadership in creating and maintaining a team-oriented work environment. What You Will Learn: Cross-Functional Collaboration: Collaborative teams and departments, broadening skillsets and knowledge base. Networking opportunities, connecting with industry experts, expand professional network. What We Offer: Relocation assistance is available. Learn More & Apply Now Collins Aerospace, a Raytheon Technologies company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio, and expertise to solve customers’ toughest challenges and to meet the demands of a rapidly evolving global market. At Collins, the paths we pave together lead to limitless possibility. And the bonds we form – with our customers and with each other -- propel us all higher, again and again. Apply now and be part of the team that’s redefining aerospace, every day.

Julio 02 2025 en Mexicali

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