Join a team recognized for leadership, innovation and diversity
Business alignment and acumen to identify regulatory needs in order to guarantee that the business strategy is successfully deployed & Identify product requirements with customers and government agencies globally with emphasis to the regulatory requirements "
Lead and Coordinate testing activities with certification partners for regulatory approvals. Provide leadership and oversight of all testing, documentation preparation, letters, technical specifications and other information requested by outside agencies to support the certification effort.
Provide monthly updates to leadership regarding country approvals, testing issues, new requirements. Work with engineering team to resolve issues with testing and communicate details to / from agency to team.
Assist the Product team regarding the new products to be launched within required and needed certifications)
Product certification updates and renewals
As assigned initiate and oversee product renewals gathering costs, schedule, lead time, sample and documentation requirements to support the effort.
Help determine impact to assigned product families and scope of work.
Track current certifications and ensure that recertification are pre scheduled / Prepare the whole process and documentation for recertification of active products of our portfolio / Assist the Product team regarding the new products to be launched within required and needed certifications
Quality & Engineering
Promote the spread of problem-solving culture through root cause investigation, HOS tool called RPS / Plan and conduct compliance audits Management Systems requirements (ISO) and regulatory requirements.
Support to customers
Evaluate and approve granting variances through technical analysis of the problem.
Maintain a continuous improvement environment by stimulating the effective use of Six Sigma and the Honeywell Operating System (HOS)
Product Line Leadership
Lead and guide product compliance specialist(s) assigned to product line to ensure certification activities are accomplished correctly and on-time.
Education level and / or relevant experience(s)
BA / BS degree (lawyer / engineering / technology / business) with 2 years of Regulatory experience & experience working in regulatory compliance field or product
In lieu of formal education, at least 2 years of progressive experience in Regulatory Areas : Engineering, Quality Control, Quality Assurance, Regulatory, etc)
Knowledge and Skills (general and technical)
Experience in creating Regulatory areas at International companies
Demonstrated strong leadership, interpersonal and communication skills
Experience with planning and attendance of external audits by customer, certification body and regulatory
Experience performing internal audits
Knowledge of quality tools for process control, standardization and problem solving
In-depth knowledge & usage of Root Cause Corrective Actions (RCCA) tools
Management of regulatory compliance tests for PPE by external and internal labs
Working knowledge of ISO9000 or equivalent Quality Management System (QMS)
Demonstrated ability as a self-starting, self-directed individual
Identification of product requirement looking for customer and regulatory specifications
Proficient using common software (MS Word, Excel, Power Point, Project, etc.)
English language on fluent level
Experience with management of PPE regulatory at Brazil and Latin America
Knowledge of ISO9001 Management System requirements
Quality, Process control, Continuous Improvement and Lean Manufacturing tools knowledge
Experience managing people and / or projects
Lean / Six Sigma
Continued Professional Development