Vice President, Regulatory Affairs
Company: Torus Biosystems
Posted on: June 23, 2022
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.
- 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,
- Track record of successful regulatory submissions including
PMA, 510(k) clearance applications, and CLIA waiver
- 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
- 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
Keywords: Torus Biosystems, Medford , Vice President, Regulatory Affairs, Executive , Medford, Massachusetts
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