Regulatory/Quality Systems Project Manager will assist in regulatory inspections, field corrective actions, post market surveillance, patient registration, device tracking, complaint reporting and MDR and vigilance reporting activities. Conducts regulatory activities with an emphasis on more complex devices or device applications with minimal. To provide senior level technical direction and consultation to clients in the development and implementation of regulatory strategies to ensure timely global commercialization of new and enhanced devices, in compliance with applicable regulations and standards (US and international). Ensures compliance with applicable national and international regulations and standards during all phases of the product life. Directs the development and implementation of systems for the preparation of quality submissions, which meet regulatory requirements to ensure timely device approval and maximize market. Assists clients in the development of documentation designed for FDA, Competent Authorities, Notified Bodies, and other related regulatory. Contributes to the development and implementation of product development, manufacturing and strategic operating. Establishes project timelines/schedules. Interacts with clients and potential clients throughout all levels of industry and corporate management. Other duties as assigned.Education/Qualifications:
Bachelor's degree plus 6-8 years applicable experience in regulatory affairs and quality systems with at least 2 years' experience as a Senior Regulatory Specialist.
- Other required work-related experience
- Demonstrated complex regulatory/quality project management experience.
- Knowledge of FDA and/or EU regulations and four or more year ' s devices submission experience.
- Project management experience preferred.
- Ability to comprehend the engineering principles, clinical, and physiological aspects of medical devices.
- Effective oral and written communication.
- Effective interpersonal skills.
- Strong organizational skills and detail-orientation.
- Demonstrated abilities to communicate cross-functionally throughout organizations.
- Familiarity with basic computer applications, g., Word, PowerPoint.
- Ability to travel (approximately 30% time).
6-8 years applicable experience in regulatory affairs and quality systems.
Apply on company website