Regulatory Affairs Specialist II

GROW WITH US:

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 a "no-shortcuts" approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the t:slim X2 insulin pump with Control-IQ technology. We're also 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. Since many of our own team members live with type 1 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.

A DAY IN THE LIFE:

This opportunity will be onsite at our San Diego Office with some hybrid options.

Supports Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories. Responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet corporate objectives. Fosters collaboration with key functional groups in Quality, Engineering, Marketing, Product Development, Manufacturing and Clinical Operations to educate and gain alignment of global regulatory strategies. Prepares, reviews, and submits applications and other filings to various regulatory agencies. Represents the Regulatory Affairs department as a member of project teams, certain boards, and as part of other meetings as the need arises.

YOU'RE AWESOME AT:

• Provides regulatory affairs support for all aspects of product development and manufacturing.

• Reviews, approves, and documents changes to devices and determines regulatory strategies for each change.

• Evaluate proposed engineering, manufacturing, labeling and quality system changes and perform global regulatory impact assessment for regulatory filings and approvals.

• Prepares letters-to-file or change notices as needed.

• Responsible for regulatory compliance activities such as unique device identifier (UDI) implementation, quality system changes, manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc.

• Ensures compliance with applicable domestic and international regulations related to Risk Management and Medical Device Reporting.

• Independently interacts with various departments throughout the company with future regulatory submissions in mind and to ensure compliance.

• Assists in preparing regulatory submissions for new product clearances/approvals including 510(k)s, dossiers, technical files, etc.

• Assists in hosting inspections from various regulatory agencies.

• Takes an active role in both internal/external audits.

• Keeps informed of current regulations, standards, policies, and guidance that impact the company's regulatory methods.

• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

EXTRA AWESOME:

• Bachelor's degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics, or equivalent combination of education and applicable job experience. Master's degree, preferred

• Regulatory Affairs Certificate, preferred.

• 2+ years of experience working in an FDA regulated industry.

• Demonstrated experience with medical device life cycle and change management

• Demonstrated ability to: work independently, quickly, accurately, follow instructions and schedules, and handle multiple priorities.

• Excellent technical writing, editing, and proofreading skills.

• Prior experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare, preferred.

• Able to apply basic scientific principles to analyze and develop persuasive speech and writing.

• Skilled at analytical problem solving and communicating with diverse groups.

• Works on multiple assignments in collaboration with various department system owners.

• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.

• Skilled at promoting team cooperation and a commitment to team success.

• Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.

• Skilled with MS Office applications, Adobe Acrobat, electronic document management systems, and other computer-based applications.

• Demonstrated knowledge of US FDA, EU MDR and Canadian regulations and guidance's.

• Experience supporting manufacturing operations, preferred

WHAT'S IN IT FOR YOU?

In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value 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.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $72,000 - $80,000 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, equity, and a robust benefits package.

Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts. You'll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem's benefits here!

YOU SHOULD KNOW:

Potential new employees must successfully complete a drug screen (excludes marijuana) and background check which includes criminal search, education certification and employment verification prior to hire.

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

REFERRALS:

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

If you are applying for this job and live in California, please read Tandem's CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants.

#LI-Hybrid #LI-Onsite #LI-DW1