With a focus on the Global region, this role is primarily responsible for project management and coordination of activities relating to regulatory submissions for the medical device products in our global portfolio. Address regulatory requests and maintain knowledge of current international regulations/guidelines/policies applicable to our products and services.
location: Exton, Pennsylvania
job type: Temporary
salary: $28 - 32 per hour
work hours: 9 to 5
- Analyze, plan and track project phases and activities, and communicating the timelines/milestones/goals with guidance on a regular basis to the leadership team and other stakeholders
- Leverage project management software (such as MS project) to develop and maintain detailed project schedules that meet the objectives associated with the defined scope and schedule.
- Coordinate with complex cross function teams with guidance to ensure timely completion of tasks and deliverables that adhere to schedules.
- Review and analyze project data and information to provide status updates, insights, conclusions and actionable recommendations.
- Schedule team meetings, draft agendas and capture and distribution meeting summary.
- Maintain effectiveness when experiencing major changes in work responsibilities or environment.
- Adjust effectively to work within new work structures, processes, requirements, or cultures
- Challenge processes remain open to ideas and changes to continuously improve and seek better alternatives and drive change.
- Adhere to all applicable government and company regulations, practices and procedures to maintain compliance.
- Successfully multi-task amongst several competing initiatives
- Education: Bachelor's in related discipline
- Experience: Minimum of 3 years of regulatory /pharmaceutical/medical device/technical/project management experience
- Knowledge of medical device regulatory affairs and design control process and management of regulatory support systems is a plus
- Experience in regulatory medical device development and registration of class I and class II medical devices
- Project management experience in a regulated industry a plus
- Demonstrated experience with tools such as FMEA, risk analysis planning and prioritization.
- Expertise with managing resource requirements
- Strong MS Project user, understand dependencies, critical path
- Excellent interpersonal, communication and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
skills: Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.