Project Manager - FDA Submissions

Project Manager

Apex Systems is seeking a Project Manager specializing in FDA medical device submissions to join our client for an immediate 9+ month contract opportunity, with high likelihood to extend.

Duties:

• Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.
• Ensure compliance with global regulations and regulating agencies.
• Interpret the intent of regulations and policies and provide such information to project teams and management.
• Instill and drive a regulatory culture.
• Establish and support policies and standards for new products. Directly, or through subordinate staff, manages the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by Company and/or affiliates.
• Develop IDE/ 510K/ PMA (US) and Technical Files/ Design Dossiers (EU) submissions for class II and III medical devices.
• Conduct submission negotiations with regulatory bodies as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.
• Maintain proficiency on regulatory requirements; develop and maintain rapport with regulatory body reviewers, project team members.
• Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Works with others as a team player to successfully achieve strategy.
• Must be cooperative and work well with all functional groups.
• Responsible for providing performance feedback to direct reports as well as coaching and assistance in their development.
• Assist in the identification and management of departmental project and personnel issues.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedure Performs other duties assigned as needed.

To the extent permitted by applicable law, candidates must be fully vaccinated against COVID-19 to be considered for this U.S. based job. In accordance with federal law reasonable accommodations for medical or religious exemptions will be considered.

Skills: Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations. Good working relationship with regulatory bodies. International clinical and regulatory experience desired. Prefer experience in the cardiovascular/cardiology field.

Education: Bachelors Degree in Engineering, Physical or Biological science or related field of study MS degree preferred. Five (5) to seven (7) years experience in the medical industry with at least five (5) years in Regulatory Affairs of Medical Devices 3 years of direct supervisory experience

Software Technology, Inc.