The incumbent has Regulatory responsibility for premarket approvals/notifications for specified BVI products. They will oversee the development and implementation of strategic and operational aspects of regulatory strategy and execution for BVI Class I, II and III medical devices. The incumbent functions as the regulatory subject matter expert on the core team, including providing input into the clinical strategy. Responsibilities include developing a strategic regulatory plan through submission and approval in key markets, and supporting product regulatory filings and registrations regionally.
New Product Approvals
Manages development, review and approval of core submission documents, regulatory documents (e.g. Clinical Evaluation Reports (CERs), General Safety and Performance Requirements (GSPR) checklists and technical summaries) and label content.
Supports the design and execution and reporting of pivotal clinical trials in line with Good Clinical Practice, BVI SOPs, FDA guidelines, and ISO standards (as applicable), including prioritizing indications, choosing appropriate populations and endpoints, planning and executing statistical analysis, and identifying Regulatory risks.
Perform tasks related to integrating and maintaining the requirements of new regulations (including, but not limited to MDSAP, MDR, FDA).
Contributes to development and utilization of a Regulatory knowledge base that can enable continuous improvements and drive efficiencies through regulatory processes, including registration management.
LCM / Change Control
Provides support to the Quality department. May serve as the backup of the QA Project Leader for the role of Independent Person (who has no direct responsibility for the project) during product design reviews.
Provides Regulatory support for experimental tests within the framework of R&D projects.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Excellent written, verbal communication, and presentation skills. Strong medical and technical writing skills with an ability to share information in a standardized format to convey complex concepts to a variety of stakeholders
Strong working knowledge of FDA and EU MDR requirements
Excellent analytical skills, with keen attention to detail
Ability to plan and deliver against project deadlines
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in engineering, biology, or related field. Advanced degree and/or RAC preferred
5 years regulatory experience in a medical device organization with Class I, II and III medical devices
Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.