Sr. Regulatory Affairs Specialist I

Tandem Diabetes Care

278d • $90,000 - $108,000 • Remote

About The Position

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 type 1 diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause.

Requirements

• Bachelor's degree in a related technical field or equivalent education and applicable work experience.
• 5+ years of Regulatory Affairs / Quality Assurance experience within an FDA regulated medical device industry.
• Demonstrated experience in writing, and submission of regulatory filings including experience authoring a range of global regulatory submissions.
• Demonstrated experience of European medical device regulations, including regulation (EU) 2017/745.
• Demonstrated knowledge of medical device regulations in other international markets, including but not limited to Canada, UK, and Australia.
• Proficient knowledge of quality standards: ISO 13485, 21 CFR Part 820 and other appropriate industry standards.
• Working knowledge of IEC 60601-series standards, specifically IEC 62304.
• Excellent technical writing, editing, and proofreading skills.
• Ability to translate and simplify technical content or regulations and communicate to stakeholders.
• Ability to dive into details, translate and statistically analyze data, and effectively report results.

Nice To Haves

• Regulatory Affairs Certificate, preferred.
• Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.
• Experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare a plus.
• Skilled at analytical problem solving and communicating with culturally diverse groups.
• Ability to recognize and correct non-conformances from accepted and documented practices.
• Skilled at promoting team cooperation and a commitment to team success.
• Skilled with MS Office applications as well as Adobe Acrobat.
• Experience with document management systems and electronic device submissions (eCopies).

Responsibilities

• Responsible for the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives.
• Coordinates the preparation, review and submission of information packages to regulatory agencies.
• Supports regulatory intelligence function for tracking updates to standards and regulations globally.
• Reviews medical device promotional materials for compliance to US and international regulations.
• Support preparation and filing of international premarket submissions as needed, including technical file preparation.
• Preparation of US regulatory submissions for new product introductions and product modifications including 510(k)s.
• Works with Regulatory leadership to assist in evaluating classification of new products.
• Collaborates and builds relationships with external partners, including Tandem's continuous glucose monitoring partners.
• Manages regulatory submission files, including required responses to regulatory agencies.
• Participates on product development core teams as the regulatory representative.
• May support clinical trial management including the planning and preparation of submissions for clinical studies.
• Keep company informed of new regulations, standards, policies, and guidance issued by relevant regulatory authorities.
• Interprets Medical Device regulations and provides direction to company in understanding the impact of such regulations.
• Identify gaps in product development plans that may pose regulatory issues.
• Reviews promotional and marketing materials for compliance with regulatory standards.
• Evaluate proposed engineering, manufacturing, labeling and quality system changes.
• Supports regulatory compliance activities, including manufacturing site registration, GMP audit, etc.
• Assists in conducting internal/external audits, as needed.
• Completes and maintains training records relevant to specific job responsibilities.

Benefits

• Starting base pay range of $90,000 - $108,000 annually.
• Health care benefits such as medical, dental, vision available your first day.
• Health savings accounts and flexible saving accounts.
• 11 paid holidays per year.
• Minimum of 20 days of paid time off (with accrual starting on day 1).
• Access to a 401k plan with company match.
• Employee Stock Purchase plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree