[Hiring] Director, Clinical Regulatory Writing @Tandem Diabetes Care

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

The Director, Clinical Regulatory Writing reports to the VP, Medical Affairs, and acts as a representative for the organization for both internal and external functions. This role is specifically responsible for developing a functional program and team dedicated to meeting the clinical regulatory needs of the business for US and global regulatory bodies. As well as hands-on work writing and supporting clinical reports including CERs, CEPs, and other clinical reports, offering clinical and regulatory expertise to support the medical writer and chief medical officer. In addition, this role may assist and support 510(k) submissions. This role interfaces with the clinical trials team to assist with study reports, study protocol development, and other areas where clinical-regulatory expertise is needed. This position also plays a key role in driving medical and clinical publications and reports.

The Director, Clinical Reg Writing at Tandem is also responsible for:

• Organizing routine communication with the regulatory division at Tandem, and mapping out a calendar of anticipated clinical regulatory needs.
• Primarily responsible for clinical regulatory writing for:
  • Writing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Literature Search Protocols.
  • Assembling templates designed to meet MDR/Canada/Australia regulatory requirements for CERs, CEPs and other clinical regulatory submissions.
  • Assistance with IFUs.
  • Other medical reports as required, to include reports needed for FDA submissions.
• Regularly updating and maintaining clinical and regulatory documents.
• Learning and working with the quality management system (QMS) to ensure compliance with company and regulatory requirements.
• Working closely with the medical affairs team.
• Working with R&D, Quality, Clinical and Regulatory functions to address and resolve any concerns.
• Assisting with clinical studies to write clinical study reports, as well as providing additional materials for clinical studies.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Identifying a team of individuals to meet clinical regulatory needs, and organizing their execution of the function.

• Bachelor’s degree (B.S./B.A.) in related field or combination of equivalent education and applicable work experience. Master’s degree (M.S./M.A.) or equivalent experience in a relevant field, strongly preferred.
• 10+ years regulatory, medical technology, clinical, industry and/or applicable experience.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• Familiarity with advanced diabetes technology and digital health products.
• Willingness to support regulatory and other functions across the company, with a direct role in medical writing (with assistance from Medical Affairs) is required.
• Comprehensive knowledge of the diabetes disease state and current therapy options.
• Ability to understand and interpret complex clinical data and other scientific information.
• Demonstrated superior verbal and written English skills, for the purpose of working with the medical writer to create and edit protocols, commercial communication and other in-scope content.
• Demonstrated knowledge of related regulatory and privacy requirements (e.g. HIPAA).
• Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
• Able to work independently and make appropriate strategic decisions to achieve the goals of the clinical affairs department.
• Proven ability to manage clinical tasks and deliverables to meet product development timelines.
• Experience with project lifecycle and management.
• Experience with agile/scrum collaboration tools and internal document control systems.
• Strong understanding of the MDR CER process is essential, including methodology of calculations of benefit to risk ratio.
• Proven knowledge and application of regulatory requirements in the EU and willingness to learn more is essential.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Advanced computer and software skills, including Microsoft Office products, and proprietary databases.

Remote: This position is fully remote and open to candidates within the United States. Equipment for the role will be provided and training will occur virtually.

The starting base pay range for this position is annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.

Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts. You’ll also receive 11 paid holidays per year, unlimited PTO and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. Learn more about Tandem’s benefits here!

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.

Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.

We love a good referral! If you know someone who would be a great fit for this position, please share!

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.