The primary responsibilities include creating regulatory strategy for new products, managing filing related activities, providing regulatory expertise on daily issues, and interfacing with outside regulatory agencies. Manage assigned product registration activities; including filing determinations, De Novo applications, PMAs, 510(k)s, Technical Documentation, IVDD, international product registrations, and annual license renewals, compile information from multiple sources for filing, guiding the project teams in creating documentation for submission, writing summaries and other necessary documentation for filing. This position reports to the Ariosa Diagnostics Director of Regulatory Affairs & Quality.
Essential duties and Responsibilities
- Represent Regulatory Affairs on project teams
- Attend product project teams meetings, as necessary, providing regulatory guidance and review
- Prepare annual facility establishment licensing renewals and product listings
- Prepare necessary product registration renewals when required.
- Establish quality system related procedures and policies for Regulatory Affairs
- Possess a broad understanding of the quality system regulations (FDA & ISO) for medical devices
- Develop regulatory strategies, templates and documentation for product registrations for each new or modified product
- Assist management in planning regulatory activities, identifying road blocks, strategizing on various regulatory paths for new products
- Actively participate with product risk management for medical devices teams
- Provide guidance in complying with regulations; assist in developing rationale and documentation for new product development, design verification, product changes, testing, design reviews, labeling changes, packaging changes, material changes, etc.
- Possess a broad understanding of medical device software requirements (device & process controls)
- Possess broad understanding of design, product, and software validation requirements
- Review and approve product labeling content
- Review and approve ECO/DCOs, as necessary
- Review and approve Marketing advertising and promotional materials
- Assist with product safety determinations
- Conduct Medical Device Reporting (MDR) and vigilance activities in a timely manner
- Conduct product corrections and removals in a timely manner
- Assist with interfacing with FDA on regulatory issues; Interface with international regulatory agencies
- Participate with internal & external audits
- Work with Quality, Engineering, and Marketing to ensure product supply
- Other duties may be assigned