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Regulatory Project Manager

Company: Comrise
Location: Redmond
Posted on: January 16, 2022

Job Description:

Overview--- Position is currently remote until COVID restrictions lift. Team members will be expected back in the office, with considerations made for possible hybrid remote schedule.

  • Under general direction, responsible for the leadership and directing of moderate complexity projects, which may require considerable resources.
  • This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent.
  • The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive.
  • The job requires attention to detail in making evaluative judgements based on the analysis of information.
  • The primary responsibility of the EU MDR Project Manager is to use project management techniques to plan and execute labeling remediation projects for our products.
  • This project manager will be responsible for multiple projects through the change management process to meet launch deadlines within a regulated medical device environment.
    Responsibilities--- Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project--- Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members--- Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle--- Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale--- Measure project performance, using appropriate tools and techniques, in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders--- Oversight of required changes and implementation processes, coordinating cross functional interactions, and driving timelines to meet business needs with stakeholders from Planning, Procurement, Manufacturing, Regulatory, Quality, Compliance, and MarketingAccountability to deliver complete labeling deliverables on time, in accordance with established procedures and within the specifications, including translations, if applicable--- Create a master labeling plan and schedule for new product development and change requests--- Manage documenting inputs for labeling and artwork projects and facilitate design reviews, as required--- Resolve or assist in the resolution of issues within and between projects or team; develop methods to monitor artwork project progress and resolve issues as necessary--- Follow up to ensure that deliverables meet or exceed expectations--- Develop, communicate, and manage project priorities, timelines and status to internal and external partners--- Proactively identify obstacles and seek resolution to ensure product changes are implemented on time--- Assist in the development of multi-country labeling strategies--- Assist with the development and implementation of the supplemental labeling process for late-stage localization--- Drive labeling-related changes through the change management process from project initiation to the verification of the label and its corresponding release into production--- Work with stakeholders to manage a process improvement project to improve the quality and predictable delivery of labeling projects--- Coordinate with Product Engineers to release updated labeling into product lines--- Manage multiple labeling projects with different deadlines by using strong project management fundamentals--- May coordinate the activities of one or more exempt and/or non-exempt employees
    QualificationsEDUCATION / WORK EXPERIENCE:--- Bachelor's degree in engineering or related field--- 4+ years' relevant regulatory or project management or equivalent combination of education and experience--- Project management training with professional certification (eg, PMP) is preferred--- Ability to generate and explain detailed proposals, schedules, objectives, and other documentation accurately--- Knowledge of design control, change control, and product labeling requirements in the medical device industry is strongly preferred--- Knowledge of FDA, ISO, and EN labeling requirements--- Knowledge of EU MDR requirements is preferred--- Experience in launching new or updated products, redesigns, line extensions or maintenance items in a medical device, food, or pharma company
    KNOWLEDGE / COMPETENCIES:--- Effective Communication Skills (Written and Verbal)--- Proficient computer skills (MS Office Suite, Outlook and Adobe Suite)--- Utilize proper software to maintain project records such as PPM system, MS Office, SharePoint, or Visio--- Strong Stakeholder/Customer Orientation and Focus--- Strong problem-solving skills; ability to identify and execute effective solutions--- Excellent interpersonal communication, collaborative teamwork and negotiation skills--- Resourceful - able to use tools, systems, and other team members to find answers--- Supports the team by pitching in at any level and effectively working across the organization to meet the needs of the business.--- Takes ownership of personal actions and outcomes; encourages and empowers others to do the same--- Embraces change; maintains an open mind and is flexible and adaptable in the face of ambiguity and change--- Detailed organizational skills--- Ability to lead and adapt to the requirements of various projects--- Ability to build new relationships and nurture existing relationships with internal and external stakeholders--- Time management skills, ability to assess and develop strategies proactively

Keywords: Comrise, Redmond , Regulatory Project Manager, Executive , Redmond, Washington

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