Would you like to take over design aspects for a medical device company with great growth potential? We are seeking an outstanding Technical Program Manager with strong quality and compliance testing to support our products through all phases of development. This is an exciting opportunity to work with a growing company who just released a unique product that is first to market. Programs involve a broad range of technologies including sophisticated laser and optical delivery systems, radio-frequency, and ultrasound devices.
- Support Program Management function in handling product development programs from proof-of-concept through production
- Provides guidance and leadership for Compliance on various projects to ensure the fulfillment of regulatory requirements and objectives
- Development and maintenance of a compliance documents such as - Critical components list, test reports, product specifications, risk management files, etc,...
- Leads and facilitates projects for the development, maintenance, and improvement of various compliance documents
- Lead communication with the testing agency for regulatory testing
- Support facility inspections and audits as required by government and regulatory agencies on a global basis.
- Shares responsibility with Regulatory Compliance on maintaining audit readiness for internal and external audits
- Liaison between R&D, Quality, Regulatory departments and testing agencies (TUV, UL, Intertek)
- Maintain Design History Files for all products
- Applied understanding of applicable US medical device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO 14971), and international regulations (e.g., CMDR - Canada, European, RDC - Brazil), IEC standards - 60601, 62304, & 62366
- Demonstrated strong leadership and partnership in working with diverse teams for improvements, issue resolution, or projects
- Experience in developing and implementing processes and procedures to comply with regulations and standards across the organization
- Strong organizational, written, and verbal communication skills; plus critical thinking skills and proficiency in constructive dialogue
- Applied knowledge of risk management, CAPA, and internal/external audit methodologies
Education & Experience
- Minimum Bachelor Degree - BS degree in Engineering, Physical or Biological Science, or other technical field. Electrical Engineering preferred.
- Five plus (5+) years' experience in compliance in the medical device (IEC 60601) or other regulated industry