Vice President, Regulatory Affairs

Company: Torus Biosystems
Location: Medford
Posted on: June 23, 2022

Job Description:

We welcome you to join Torus Biosystems as our VP, Regulatory Affairs The OpportunityThis newly created position is ideally suited for an established, hands-on regulatory leader who has expertise in the molecular diagnostics industry. You will be joining a dynamic and entrepreneurial leadership team and will report directly to the Chief Executive Officer. Your RoleThe Vice President, Regulatory Affairs will be responsible for developing and implementing all strategies, policies, and programs (including monitoring mechanisms) in support of Torus Biosystems pre- and post- market regulatory activities. This role oversees the development of strategies for regulatory clearance applications at all stages of medical device product development and manufacture. Key Responsibilities

• Oversees the design and implementation of regulatory strategies, operations, and compliance systems supporting the development and commercialization of the Torus Biosystems product portfolio of clinical diagnostic devices.
• Establishes and maintains effective communications with US FDA and global regulatory bodies on behalf of the company.
• Collaborates and coordinates with internal stakeholders (R&D, QA/QC, legal, marketing) to ensure all aspects of product development are aligned with regulatory requirements associated with medical device commercialization.
• Ensures all activity that occurs within the product development lifespan meet federal and state guidelines. Develops and implements an appropriate risk management process in support of contemplated product regulatory clearance submissions.
• Assembly of all regulatory clearance submission data packages for Torus Biosystems products.
• Manages all relevant regulatory permits and licenses in support of commercialized in vitro diagnostic products. Qualifications and experience you bring to the role
  • Bachelor's degree or equivalent. Advanced degree a plus. Bachelor's Degree in relevant scientific or technical discipline (e.g., engineering, biology, chemistry, etc.)
  • 12+ years of medical device regulatory affairs experience
  • 5+ years managing U.S. regulatory programs in the in vitro diagnostics (IVD) industry (or an equivalent combination of education and experience).
  • Thorough knowledge of FDA requirements and approval process for molecular diagnostic products, including instruments, consumables, and software.
  • Track record of successful regulatory submissions including PMA, 510(k) clearance applications, and CLIA waiver applications.
  • Demonstrated proficiency with medical device design history files and quality systems.
  • Demonstrated experience in medical device clinical development, product development project teams, medical device labelling, and post-market product surveillance.
  • Track record of consistently meeting timelines and budgets.
  • Willingness and capability to handle multiple programs and responsibilities within time constraints.
  • Superior written & verbal communication skills.
  • A hands-on, entrepreneurial mindset. Torus Biosystems is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, veteran status, or other class protected by applicable law.We believe in building diverse teams and encourage people from underrepresented backgrounds to apply.

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