Regulatory Agency Communications Lead

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role

Responsible for the written communications between Vantive and regulatory agencies in response to questions or requests within the Vantive quality management system. Responsible for following and (as needed) adjusting the regulatory agency communications process, globally and company-wide. Responsible for tracking and trending all regulatory agency requests.

What You'll be doing

• Responsible for the coordination, filing and tracking of all regulatory agency inquiries and responses for Vantive
• Uses technical writing expertise to draft and finalize regulatory agency responses
• Provides support and ensures regulatory agency responses and inspection response status updates are accurate, complete, on-point, and submitted on-time
• Coordinates and leads team meetings with Subject Matter Experts (SME’s) and stakeholders to drive responses for inquiries from regulatory agencies
• Maintains a high level of expertise in current regulatory requirements, and serves as a resource for compliance to these requirements
• Interacts frequently with leaders, SME’s, and functional technical experts

What You'll Bring

• Bachelor degree required, Master degree preferred
• 5+ years of experience
• Proven Technical Writer
• Must be able to take information (technical, product specific, scenario based, etc.) from SME’s and summarize for responses
• Excellent interpersonal skills; must have excellent written and oral communication, influencing/negation skills to maintain effective and trusting relationships with internal/external customers
• Good project management and organization skills
• Thorough knowledge of procedures, regulations and standards (e.g. FDA Regulations, Good Laboratory Practices, Good Manufacturing Practices, etc.)
• Experience interacting with regulatory agencies such as US FDA, EU notified bodies, Health Canada, etc.

Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000-132,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future.  The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently.  The plan offers a robust set of investment options, finan