• 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.
YOU MUST HAVE
• 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
• Quality experience
• 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
• 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