Job Description :
Position: Project manager
Location: West Chester, PA or Cincinnati Ohio
Duration: 12+ Months
Job Description:
Skills:
File and maintain regulatory deliverables.
Project management experience.
Co-ordinate with cross functional team to complete the technical files.
Create and complete technical file submissions; communicate with authorities regarding these submissions.
Prepare Matrix and charts, data points for review meeting with management.
Identify any clinical data requirements for product licensing globally and insure the requirements are documented in the compliance plan.
Technical Skill:
Must have ability to develop and maintain business partnerships at all levels of the organization.
Expertise / proven record of working with onsite-offshore business model on mechanical engineering projects.
Adheres and comply to work instructions, Standard Operating Procedures.
Knowledge of project management in medical device field.
A Bachelor’s degree in mechanical or related discipline, with a minimum of 4 years experience in the medical device industry or healthcare field is required
Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans / reports strongly preferred.
Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with minimal supervision.
Ability to communicate effectively and work with teams is required.
Previous experience developing strategies to generate clinical evidence is strongly preferred.