Job title: Principal Regulatory Affairs Specialist
Job location: Fully remote – east coast preference – must be open to traveling
Benefits: Medical, Dental, Vision (starts on the 1st of the month following start date), 401k 6% matching, 120 hours PTO
Education: Requires a four-year degree, in a technical field or scientific discipline (Biology, Engineering or Physical Sciences)
Required Experience: Minimum of eight years of medical device regulatory affairs experience.
This position is responsible for ongoing regulatory compliance and determining current and prospective medical device regulatory requirements in order to satisfy projects and objectives. Defines and develops the strategies along with the information and actions necessary to meet these requirements.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Develops and implements regulatory strategies for projects and products, including both domestic and foreign activities, and provides regulatory consultation to other internal and external entities.
- Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
- Responsible for the preparation, review, and submission of domestic and global regulatory applications in order to obtain product registration.
- May serve as Recall Coordinator to provide oversight for recall activities which include recall strategy, recall plan development, preparation of 806 submission and monthly reports to FDA, initiating customer communications to all stakeholders, oversight of field action execution globally, and tracking of steady state metrics. Ensures the completion and reconciliation of all required elements of a recall plan.
- Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs staff and cross functional teams as required.
- Develop, review, and provide input on departmental policies and procedures.
- Supports highly technical, special projects, or strategic initiatives.
- Maintain a current knowledge of global medical device regulations pertaining to the distribution of products, which include facility registration and device listing.
- Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
- Maintain documentation and a historical record for projects and provide management with updated product status.
- Demonstrates the ability to interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels.
- Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
- Must be able to provide leadership and direction to other regulatory associates in absence of regulatory management. May serve as delegate.