Regulatory Affairs Manager

ABOUT

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 30 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 a small blood sample in minutes in a retail setting or private clinic.

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. Join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers!

JOB SUMMARY

Truvian is looking for an onsite Regulatory Affairs Manager. This position establishes and manages all Truvian Regulatory submissions and registrations by working with the Head of Quality and Regulatory and various functions as required. This ensures priorities are established and there is coordination/collaboration with the functional groups to ensure regulatory deliverables are met. This includes oversight of regulatory filings in the US and worldwide, e.g., those prepared under US FDA Regulations and/or country-specific country requirements/regulations, including ensuring compliance with current and future CE Mark/IVDR requirements. Acts as a liaison between other departments regarding current FDA and worldwide regulations and operating procedures. Ensures processes are in place to ensure the Senior Leadership team and others are kept abreast of all changes to existing standards and/or regulations/requirements for FDA and worldwide regulations. This role must coordinate, prioritize, and align with the Business Goals/Objectives. FDA Submissions and worldwide/global required registrations, licenses, and reports are submitted per established timeframes, including appropriate follow-up.

HERE’S WHY YOU’LL LOVE THIS JOB:

• You will be setting the strategy and managing every aspect of Truvian’s Regulatory Activities…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 and 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), paid parental leave, 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 delivers Truvian’s diagnostic products into diverse, global end markets.

This will require:

• Develop strategies and timelines that support commercial plans for global commercialization.
• Working with the product development team, craft regulatory submissions are required to obtain premarket approval for products in all countries where products are to be sold.
• Prepare pre-submission packages, 510(k)s, and international product registrations and manage the regulatory submission process through to approval for IVD products, including consumables and instrumentation/software.
• Interface directly with outside international distributors, governmental regulatory personnel, scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications.
• Inform Senior Management team of significant issues or developments identified during regulatory activities and actions being taken to improve the situation.
• Ability to appropriately interpret existing and emerging regulations, standards, or guidance documents, including the potential impact on regulatory function.
• Support the review and approval of assigned product labeling, advertising, and promotional materials to ensure compliance with all applicable FDA and other relevant regulations and industry guidelines.
• Independently review changes in products, product specifications, and manufacturing processes to assess the regulatory implications of the change.
• Responsible for organizational policies and standards to maintain regulatory compliance and maintain responsibility for implementing such policies and procedures.
• Utilize a constructively assertive approach that reaches out, speaks up, and drives continuous improvement.

WHAT YOU WILL BRING:

Required Bachelor of Science, highly preferred Masters’s Degree in life sciences, and a minimum of 7 years of relevant experience in regulatory, ideally in the in-vitro diagnostics and CLIA Waiver. Basic laboratory and clinical experimental skills. Must write clear, understandable technical documentation, i.e., regulatory documentation or scientific presentations. Ability to mentor, follow, and accurately give clear written and verbal directions. Skilled at analyzing data and summarizing results. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

BS/MS in life sciences and at least 7 years of experience in regulatory affairs, focusing on in-vitro diagnostics and CLIA Waiver. Good problem-solving, judgment, and decision-making skills are required. Experience with successful preparation and submission of Technical File, Pre-Submission, 510(k), CLIA Waiver, international documents or registration, and a good understanding of the multiple routes to clearance of a CLIA Waived diagnostic product. Action-oriented with an understanding of the process. Resourceful and hands-on. Ability to see the framework of the over-arching IVD landscape and inform how the company continues to evolve as part of that larger picture. Strong working knowledge of FDA regulations, including knowledge of IVD development process and related FDA regulations across the entire product life cycle. Ability to take initiative and work autonomously without significant direction, implementing judgment to resolve objectives. Outstanding interpersonal and communication skills, ability to lead through influence and drive change. Strong project organization and time management skills, including prioritizing multiple challenging project timelines while meeting all deadlines. Strong technical writing experience is required. Ability to handle and resolve conflicts and work under schedule/milestone pressures. Highly organized and detail-oriented, with an analytical approach to problem-solving and decision-making.

The ideal candidate will have extensive experience in:

• Achieving impossible timelines through a combination of superior planning, proven assessment of risk, and the ability to inspire and enable others to move fast
• Partnership and collaboration, ensuring relationships are at the forefront of our strategy, emphasizing the company and team over personal goals, and the ability to
• Communication, both oral and written, with the ability to communicate frequently, clearly, and timely while keeping both internal and external parties aligned to deliver impact at pace
• Tools including experience implementing and working in ERPs, Microsoft Office products, and more
• Problem-solving, with solid analytical skills, which can be utilized to proactively identify and address issues with a solution-oriented approach with excellent time management skills

SALARY RANGE

$126,000 – $140,500 Annually. This range considers the factors considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary offers are determined based on the final candidate’s qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.

SUPERVISORY ROLE

• No

PHYSICAL DEMANDS AND ABILITIES

Regularly required to use hands to finger, handle or feel, reach with hands and arms, and talk or hear. Ability to lift and move over 25 lbs. repeatedly and safely, occasionally 75 lbs. with assistance. Frequently required to stand, walk, stoop, kneel, crouch or crawl. Occasionally required to sit and climb or balance. Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus. If you want to stand out, please include a cover letter.

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.

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