Descripción del Trabajo
The Regulatory Affairs Specialist will support NP Medical’s global regulatory activities and submissions. This role will assist in the preparation of regulatory submissions and the support of regulatory processes for NP Medical’s products to ensure compliance with regulatory requirements in the US and EU.
Additional responsibilities may include regulatory support for Manufacturing and Quality Assurance. A successful individual in this role will need to be highly organized, detail oriented and able to balance multiple priorities under aggressive timelines.
- Assist with U.S. FDA submissions (510(k)).
- Manage the post-market surveillance process.
- Support EU MDR and MDSAP implantation.
- Provide regulatory product support including regulatory review of product change plans and CAPAs.
- Acts as a regulatory representative on product development teams, communicates regulatory requirements and impact of regulations to the development team.
- Lead the clinical evaluation process throughout all portions of the product life cycle and align with EU MDR requirements.
- Assist in preparing documentation for adverse event reporting, as required.
- Update the risk management process to align to revised standards.
- Work with suppliers and customers to resolve material compliance questions.
- Research, understand and communicate regulatory requirements.
- BS/BA degree required in science/health-related field.
- 8+ years of hands-on experience performing Regulatory Affairs/Quality Systems activities in a medical device company.
- Experience with regulatory submissions in the US and EU: 510(K), and CE Technical Documentation.
- Experience and understanding of the development process for medical devices.
- Deep understanding of US FDA regulations, MDD, ISO13485, ISO 14971 and EU MDR is required. Understanding of CMDR is a plus.
- Ability to understand scientific and technical aspects of Class II/IIa medical devices.
- Experience with private labeling desired.
- Excellent oral and written communication skills.
- Highly collaborative, and works effectively in teams.
- Demonstrates strong analytical and problem-solving skills with attention to detail.
- Highly organized with the ability to manage multiple priorities, meet deadlines, and be flexible to changing priorities.
About Our Company
NP Medical Inc., a Jabil company, is an innovator and supplier of medical devices that address the large-scale needs of the infusion therapy, vascular access and respiratory protection markets. The goal that motivates us every day is to provide compelling product solutions that make quality patient care possible by improving patient outcomes and caregiver safety at an affordable cost. It is a deep understanding of the consequence of our work that has fueled NP Medical’s product innovation, guided our daily operations, and defined our customer and caregiver engagement for over thirty years. This rich tradition has produced an enduring and winning culture marked by excellence, compassion, and collaboration that extends to our customers, caregivers, and patients alike.