Truvian Sciences Senior Vice President, Regulatory Affairs in San Diego, California
Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated, benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic.
To us, our work at Truvian is more than a job ? It?s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today?s connected consumers!
Truvian is looking a Senior Vice President of Regulatory Affairs who will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions for Truvian?s diagnostic products. In this role, you will oversee Regulatory Affairs (and potentially quality assurance / clinical operations) for Truvian?s point of care IVD blood testing platform and panels. You will be a cross functional leader working with R&D, operations, commercial, marketing and lead/build a best in class team. This position will report directly to the Chief Executive Officer.
HERE?S WHY YOU?LL LOVE THIS JOB:
You will be setting the strategy and managing every aspect of Truvian?s regulatory affairs?there is a lot to do!
You'll work with a rock star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products
You?ll be a key player on a team responsible for the company?s growth and product launch
You thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
You?ll have great perks such as: Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on site gym and virtual classes, and a farm to table onsite restaurant including a 30% discount
WHAT YOU WILL DO:
Broadly, this role is responsible for Truvian?s regulatory affairs. This will require:
Develops and directs the pre-market and post-market regulatory strategy for U.S. and international markets
Work collaboratively with regulatory agencies to define the submission strategy and agency review process for a novel device that spans multiple review groups at one time
Directs regulatory compliance initiatives, including the planning, coordination, and interface with regulatory agencies.
Collaborate with Quality Assurance regarding facility inspections including the coordination of timely responses to findings
Acts as corporate liaison to relevant regulatory and standards organizations
Provides oversight and direction regarding relevant business decisions for Truvian
Builds, develops, trains best in class RA (and subject to candidate qualifications QA, CA) team(s)
Responsible for identifying areas of potential regulatory compliance risks and oversees development of programs to mitigate any potential risk
Builds partnerships with business leaders, teams, and stakeholders to provide best in class technical guidance to maximize Truvian?s long-term business objectives
WHAT YOU WILL BRING:
The ideal candidate will have extensive experience in:
Experience with Quality Assurance and/or Clinical affairs in diagnostics
Broad Regulatory Affairs experience working with the US FDA and global regulatory agencies in the In Vitro Diagnostics (IVD) industry
Demonstrated track record of successful regulatory submissions
Creative thinker who has demonstrated the ability to gain regulatory approval for a novel device or application
Possesses a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development.
Ability to read, understand and interpret medical device, FDA and EU regulations and requirements
Excellent communication skills required, written and verbal. Write procedures; perform presentations to staff and management.
The candidate will have 10+ years experience progressive Regulatory Affairs leadership experience in diagnostics (IVD), medical device or regulated industry (FDA/cGMP/ISO), with responsibilities for managing others and B.S. degree in Life Sciences, Computer Science, or Engineer (advanced degree preferred).
If you want to stand out, please include a cover letter
- Open to relocation
PHYSICAL DEMANDS AND ABILITIES
Prolonged periods of sitting at a desk and working on a computer
Must be able to lift 10 pounds at a times
Truvian provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.