Position Title: Regulatory Affairs Specialist II
Corindus Vascular Robotics, Inc. is a global technology leader in robotic-assisted vascular interventions. The company's CorPath® system is the first FDA-cleared medical device to bring robotic-assisted precision to percutaneous coronary and peripheral interventions. Corindus is advancing the field of interventional medicine with robotics through improvements to procedural control, precision and workflow.
This position is responsible for the creation, preparation and coordination of regulatory submissions and approvals in the domestic and international markets. As part of a multi-disciplinary group, this position contributes to the design, development and product launch of Corindus’ innovative robotic systems that bring improved care to patients and physicians.
- Work with the Manager of Regulatory Affairs to determine effective regulatory pathways for a variety of projects and issues
- Prepare document packages for regulatory submissions including 510(k)s, Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions, and Pre-market Approval Applications
- Track and coordinate regulatory submission activities to ensure timeliness and commitments are met
- Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval process
- Review and approve Engineering Change Orders in accordance with regulatory requirements
- Participate in new product development teams and communicate regulatory requirements for product development; facilitate internal compliance with those requirements
- Review and approve test protocols to support regulatory submissions
- Review device labeling and advertising material for compliance with submissions
- Assist in regulatory compliance activities, including but not limited to Notified Body Audits, FDA Inspections, and other regulatory agency inspections and audits
- Maintain regulatory files
- Perform internal audits of the Quality System
- Analyze product complaints and make recommendations regarding their reportability
- Other duties as assigned
- Bachelor’s in Engineering or Science required. Advanced degree preferred.
- Experience in a medical device, biotech or pharmaceutical environment required
- Regulatory compliance experience in the medical device area preferred
- Knowledge of applicable US and EU medical device regulations required. Knowledge of other markets is required
- Regulatory submission experience in US and EU required
- Working knowledge of GMPs and GCPs required
Organization: Siemens Healthineers
Company: Corindus, Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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