Regulatory Specialist - Knee
2320 NW 66th Court Florida, FL
As a regulatory specialist for a major Orthopedics manufacturer you will prepare and maintain FDA & international product registrations for medical devices.
- Ensure that all procedures, processes, and documentation meet guidelines for FDA compliance, including Design Control & Risk Management processes
- Prepare & Maintain FDA pre-market submissions as well as international product registrations
- Prepare & Maintain CE Mark Design Dossiers and Technical File for review by the Notified Body
- Provide regulatory support for new product development process
- Participate in complaint handling process, internal quality audit process, and CAPA activities.
- Review and approve product labelling
- Provide support and guidance for other employees as necessary
- 2+ Years Experience in FDA/ISO Medical Device Quality Management Systems
- Experience in preparing FDA pre-market submissions (whether 510(k) and/or PMA) and international registrations highly preferred
- Nuanced understanding in Design Control
Compensation: Commensurate with Experience
FDA pre-market submissions (510(k)
Arshad is a seasoned recruiter in the healthcare space with over 15 years of experience in promoting career growth for healthcare professionals. He has played a critical role in the launch of several startup companies. He is known for versatility and leadership; expert in overseeing high-level priorities and a broad range of responsibilities.