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Regulatory Affairs Manager
San Jose-based, Visby Medical is an ambitious, well-funded, and fast-paced early-stage biotech start-up. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Visby is developing a novel diagnostic device platform that aims to redefine the way infectious disease is tested and treated.
The Manager of Regulatory Affairs is responsible for the preparation and support of regulatory submissions and product registrations required to market in vitro diagnostic (IVD) devices in the U.S. and international markets. Requires strong technical writing skills, problem solving, attention to detail and ability to collaborate across departments. Responsible for researching and effectively applying regulatory requirements to Visby’s IVD products, including development of product labeling, standard operating procedures, project plans and regulatory strategy, as appropriate. This position requires a strong understanding of regulatory principles and strong organizational skills.
What you will do
Primary QMS Responsibilities:
- Lead and manage all aspects of preparing and filing regulatory submissions (510(k), CLIA Waiver, technical files) and obtain required regulatory clearances/approvals.
- Conduct regulatory analysis and propose regulatory strategies for Visby’s IVD products.
- Review and approve verification and validation and reports to ensure appropriate data for regulatory submissions and regulatory compliance.
- Author, review and/or approve product labeling to ensure compliance with regulatory requirements.
- Review promotional and advertising materials to ensure regulatory compliance.
- Research and interpret regulatory requirements and effectively communicate requirements to Visby stakeholders.
- Write and update QMS documents required for regulatory compliance and to meet regulatory requirements.
- Stay current on regulatory requirements related to Visby’s products in relevant markets.
- Serve as core team representative on product development teams for regulatory affairs and establishes regulatory strategy
Primary Non-QMS Responsibilities:
- Prepare and deliver effective presentations.
- Ensure communication among internal and external groups as necessary to achieve major contributions to the company’s developing assets.
On your first day we’ll expect you to have
- BS or BA in a Scientific field. MS or Ph.D. in a Scientific field, preferred.
- Minimum 5 years of experience with a Bachelor’s degree; Minimum of 3 years with a Master’s degree or minimum of 2 years with a Ph.D.
- At least 3 years of experience in FDA regulated industry, or similar. In-vitro diagnostic experience, preferred. Molecular infectious disease experience preferred.
- Working knowledge of industry consensus standards and FDA guidance.
- Recent experience with implementation of the IVDR and international labeling requirements.
Unique aspects of this role
- Proficient in using Microsoft Office and equivalent Google applications
- Polished technical writing and oral communication skills
- Strong project planning, management and prioritization skills
- Able to handle multiple tasks with a high attention to detail
- Able to adjust plans to changing requirements.
- Comfortable performing repetitive tasks and/or motions.
- Must be able to lift a minimum of 10 lbs.
- Unless an employee has been granted an exemption based on a medical disability or based on a sincere religious belief, observance, or practice, full vaccination for COVID-19 and proof of full vaccination is required. As a condition of employment with Visby, please be prepared to show proof of vaccination along with your other required legal documents on your first day of employment.
More about the team
Our team is dedicated to obtaining regulatory clearances/approvals for Visby’s innovative IVD products so that anyone can test for any infectious disease anywhere with high accuracy. The regulatory team is dedicated to removing regulatory barriers so that all individuals can obtain accurate test results that support informed and effective management of infectious diseases.
More about our benefits
Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We also offer a 401k match, flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.
We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone’s perspectives and experience we never discriminate on the basis of race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status.
Learn more here
Job posted: 2022-04-24