117 Manager Regulatory Affairs- Medical Device
Manager Regulatory Affairs - Medical Device (Job ID: 117 MQA)
Miami, FL
Position Summary:
The Regulatory Affairs Manager will design and implement strategies to garner government approval for new products and technologies produced by an orthopedic company providing innovative solutions to the minimally invasive joint replacement industry. The position will be responsible for providing expertise on domestic and global regulatory requirements, as well as for preparing submissions to various regulatory agencies, and negotiating product approval from those regulatory agencies. This individual will also support all post-market activities.
Primary Responsibilities:
- Provide expertise and direction on necessary regulations in US, EU, Asian, and other international arenas
- Provide daily management of regulatory compliance with regard to CAPAs, complaints, MDRs, corrective actions, general control compliance, compliance with special controls of the FD&C Act, and the EU
- Design and implementation of regulatory submissions and approvals for the launch of new products domestically and internationally
- Preparation of Regulatory documentation, including “Letters to File” for product changes, ”Permission to Export” for foreign registration, facility registration and device-listing documents
- Review Marketing related content for adherence to regulatory requirements
- Assist in performing internal quality audits, and quality system training
- Ensure proper regulatory staffing for the company
Education Requirements:
- Bachelor’s degree in Science or Engineering
Position Requirements:
- 5+ years of experience with Class II and III medical devices REQUIRED (sorry, no exceptions)
- Experience with regulatory agencies, both domestic and international
- Strong knowledge of orthopedic devices and procedures
- Work experience with production and managment of medical device regulatory submissions for Class II and III products
- Work experience with complex medical devices (e.g., image guided surgery, medical equipment with software guidance)
- Must be proficient with MS Word, Excel, Project, Visio, and Power Point
- Must have excellent verbal and written communication skills and experience interacting with top management
- Must have a demonstrated problem-solving ability, and must be a self-starter
For additional information, please visit our website at www.LegacyMedSearch.com
December 28th, 2007 at 5:10 pm
Please be aware that my husband and I are looking to relocate in the southern US. His background includes over 30 years in operations and Q&R for medical devices, e.g. VP, Director, etc. He can be contacted at the above email address.