Regulatory Affairs Project Manager

Main Purpose of Job

The Regulatory Affairs Project Manager will oversee, manage, lead and participate in Global RA projects, optimize and harmonize processes, and develop global templates. This position will be responsible for communicating the status of RA projects to the management team. The Regulatory Affairs Project Manager will also apply lean management and facilitate workshops to optimize processes.

Role and Responsibilities

• Lead and participate in projects as assigned to optimize regulatory processes and facilitate best practices
• Collaborate and support the Regional RA and cross-functional teams to ensure global tasks and projects meet timeline
• Develop and maintain the global regulatory strategy
• Provide oversight for the tracking of regulatory activities, database maintenance, and ensure that records are complete, accurate, and current
• Work with IT and RA team to implement RIMS
• Coordinate the maintenance of work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, trackers, etc.
• Help alleviate roadblocks with the RA team by working with cross-functional teams
• Work closely with other Project Managers to track tasks and deadlines and to keep RA team members accountable as well as cross functional team members
• Independently lead problem-solving and decision-making activities, within the scope of the project.
• Facilitate communication with cross functional teams and send routine correspondence by presenting and sharing regular updates
• Maintain/update regulatory databases, spreadsheets, project trackers etc., assuring that they are current and accurate
• Track the status of products/projects that are in new product development and life cycle management in all markets
• Assist to resolve any submission related issues for projects, and escalate any critical activities that could impact the approval and/or launch of a product in the respective market
• Build a database to support the tracking of projects in the pipeline to allow for timely updates
• Interact with colleagues across Hoya sites globally; lead and participate in meetings across multiple time zones
• Collect, track, and report against launch timelines. Review documents, identify problems, seek information/data from the individual departments
• Act as a resource between departments within the organization to ensure that project priorities and action items are accurately communicated to the appropriate personnel
• Prepare metrics, scorecards and presentations as requested by Senior Leadership
• Support other projects and assignments as requested.

Experience

• 7+ years of Global RA experience
• 4+ years of Project management experience

Education

• Bachelor's degree required; advanced degree preferred.
• Preferably in science or engineering field

Skills

• Must be well versed in Global medical device requirements particularly in EU, US, Japan, China, Australia, and Korea
• Ability to work within a team and as an individual contributor in a fast- pace changing environment
• Ability to leverage and engage others to accomplish projects within the RA and cross functional team
• Ability to solve complex problems with a variety of variables through nonstandard solutions that require in-depth analysis
• Experience in facilitating workshops
• Lean six sigma certified preferred
• Must possess a high-level of proficiency with Microsoft Excel and PowerPoint with attention to detail. Must have the ability to multi-task and work well under pressure

Travel Requirement

• Approximately 20%