Manager, Regulatory Affairs And Compliance

**Job Summary**A high-performing individual to provide hands-on leadership to the Finished Device Solutions (D&D) team, and to be a key individual in the areas of Quality Management.Medical device development and manufacture experience is essential.Injection molding experience is also a strong plus.The individual will possess a broad range of medical device quality skills and experience, a record of leading and participating with teams from product concept through validation and into manufacturing, as well as in-depth knowledge in several clinical and product areas.This individual will also play a key role in mentoring less experienced employees and must be self-motivated and excited by the prospect of working in a dynamic, entrepreneurial environment.**Essential Job Duties and Responsibilities****Qualifications**- An experienced individual to provide hands-on leadership for the Manufacturing (D&D) team, who will champion the Nordson MEDICAL New Product Introduction (NPI) Process.- A committed individual with working knowledge of Medical Device Manufacturing and a proven track record of scaling processes and systems to meet business growth needs.- A professional with expertise in Regulatory Compliance knowledge for the applicable regulatory requirements to support our customers for the Design Control and Manufacturing activities.- This individual will work closely with the Operations and Engineering team leadership to drive and grow the business to meet the strategic objectives of the organization.- This person will possess the strategic skillset to develop the plans and structure to ensure successful growth without compromising regulatory compliance or quality standards.**Responsibilities**- Has the ability to discern an appropriate course of action based upon multiple proposed solutions.- Typically lead large scale and technically complex projects or projects that have an ambiguous scope or project path, while demonstrating strong interpersonal skills that enable substantial cross-functional influence.- Regularly interact with the customer and have broad knowledge to understand what the customer wants even if requirements and direction are not clear.- Provide mentorship to engineers and manage teams, setting appropriate goals and giving direction.- Has decision making skills to select the members of their team.- Provide strategic project direction and ensure that technologies are up-to-date and identify technical gaps and takes action to address them.- Their work is performed without appreciable direction and they exercise considerable latitude in determining technical objectives of their assignments that they complete or delegate to their team.**Job Duties**- Provides technical support to Manufacturing and Product Engineering regarding validations, test method validations, and statistical analysis.- Supports the planning, development, implementation and maintenance of manufacturing methods, processes, and operations for new and existing products as well as the design and manufacturing of new tooling and equipment.- Supports the Value Stream Model for coordinating activities, including Continuous Improvement projects and management of Quality tasks.- May conduct evaluation, approval and performance monitoring of suppliers.- Ensures the identification, segregation, and disposition of nonconforming material and processes have been established for the facility.- Provides sustaining Engineering support to resolve manufacturing issues in the plant and with the customer.- Participate in/lead lean and cost reduction activities.- Leads & conducts investigations and associated actions related to CAPA and Internal/external audit activities.- Ensures that investigations and associated actions related to customer complaints are executed in accordance with procedures.- Performs Internal audits as needed.- May execute/host external audits.- Maintains Quality System implementation with procedure and form maintenance and development.- Ensures that all direct reports are efficiently utilized and billable at target levels.- Participates in the organization and execution of interdepartmental activities to ensure the completion of projects on schedule and within budget constraints.- Interacts with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information.- Writes and/or reviews proposals for prospective projects.Ensures all proposals are professionally done and contain accurate technical content, costs, and time estimates.- Ensures that all work satisfies the requirements of the company's Quality Manual, with emphasis on Manufacturing Controls.**Education and Experience Requirements**- Degree in Engineering- Experience in medical device is essential, minimum ten (10) years, quality leadership desirable- Experience in Operations / Manufacturing of Medical Devices preferred- Experience with