Director of Regulatory Affairs
About The Position
Neuros Medical is a privately held medical device company focused on improving the lives of amputees with chronic post-amputation pain. Their innovative Altius® System, approved by the FDA, offers a non-opioid solution for managing this debilitating condition. This patient-controlled device uses electrical nerve stimulation to target and reduce pain signals, leading to significant improvements in quality of life. With a commitment to patient well-being and cutting-edge technology, Neuros Medical is dedicated to providing effective treatments for those suffering from post-amputation pain. Why You Should Join Us This is a Director of Regulatory Affairs role. You will have the opportunity to be responsible for providing regulatory support and guidance to project teams and regulatory staff and preparing and submitting FDA submissions for approval. Manage the process from the development of regulatory strategies through to approval. Ensure compliance with all U.S. regulatory requirements.
Requirements
- A Bachelor’s Degree in Science of Life Sciences, Engineering, or equivalent (MS preferred).
- 5-10 years Regulatory Affairs experience and a successful track record preparing submissions for Class III products.
- Ability to work independently and multitask in a timeline driven start-up environment.
- Solid knowledge of US and European regulatory processes.
- Extensive experience and a track record of successful preparation and submission of Pre-IDEs, IDEs, PMA supplements, Technical Files, Dossiers and amendments.
- Excellent verbal and written communication and presentation skills, including experience presenting at FDA meetings.
- Ability to communicate clearly, succinctly, and effectively over the phone and in writing with various clients, including Regulatory Agencies.
- Strong interpersonal skills and management experience.
- Ability to recruit, develop, and retain staff.
- Willingness to work a flexible schedule.
Responsibilities
- Work to devise regulatory strategies to ensure rapid and timely approval of devices.
- Interpret existing or new regulatory requirements as they relate to company products and procedures, clinical studies, testing, or records keeping.
- Provide regulatory guidance and support to project teams including regulatory filing strategies, testing and standards requirements and support RA staff in filing process.
- Review, analyze and approve technical data generated by Research and Development, Manufacturing, Marketing, Clinical Research, Quality Assurance or other related departments for filing purposes.
- Review, provide feedback and approve design and manufacturing changes, nonconforming materials reports, rework orders, test protocols and reports to ensure regulatory compliance with FDCA, MDD and applicable standards, and determine filing requirements.
- Review promotional and advertising materials, complaints and lead vigilance and MDR reporting efforts.
- Prepare US regulatory submissions, including, but not limited to IDE/IDE Supplements, 510Ks, PMAs/ Supplements, Annual Reports, Technical Files, and Design Dossiers and Change Notices.
Benefits
- Medical, Dental, Vision
- Basic and Supplemental Life, AD&D Insurance
- Disability
- FSA and HSA
- Various Additional and Voluntary benefits
- PTO
- Corporate Holidays
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What This Job Offers
Job Type
Full-time
Career Level
Director
