Regulatory Affairs Associate
Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding.
Please refer to these associated links to learn more about Cresilon:
The RA Associate is responsible for day-to-day regulatory submission work, assisting corporate compliance with applicable laws and regulation, and conducting regulatory assessments. The RA Associate adopts and maintains a culture of excellence and quality in all aspects of his/her job function. The RA Associate works in a highly-regulated environment and aids in ensuring that the Quality Management System methods and Quality System Regulations are applied throughout Cresilon.
- Assist with the preparation and maintenance of medical device regulatory submissions, including US 510 (k)'s, de novo applications, IDEs, EU Technical File/Design Dossiers, and other international documentation as required.
- Participate in the design and execution of domestic and international regulatory strategies
- Maintain up-to-date knowledge on international and domestic regulatory requirements.
- Participate in and provide required deliverables to development teams as the internal regulatory team member and FDA liaison throughout the product development cycle, submission, pre-approval, launch and post marketing phases for assigned projects. Tasks include review, input, and approval of test protocols and reports, FMEAs, clinical documentation, and all related documentation requiring RA input for project development teams.
- Conduct regulatory assessments, review and approve manufacturing and design changes as appropriate.
- Review and approve promotional material as required.
- Other duties may be assigned as deemed necessary by the supervisor.
- BS or Master’s degree in Engineering or Science, or equivalent
- 3+ years’ experience in applicable domestic / international submissions, design control systems and/or regulatory compliance
- 1+ years’ experience with medical device regulatory submissions
- Excellent oral communication and technical writing skills
- Successfully submitted regulatory communications and updated technical files
- Understanding of FDA and EU regulatory requirements for medical devices