Regulatory Affairs Specialist
1 day ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.
Key Responsibilities- Prepare and maintain domestic and international regulatory filings to meet corporate objectives.
- Coordinate the preparation, review, and submission of information packages to regulatory agencies.
- Support regulatory intelligence function for tracking updates to standards and regulations globally.
- Review medical device promotional materials for compliance with US and international regulations.
- Collaborate with external partners, including Tandem's continuous glucose monitoring partners.
- Manage regulatory submission files, including required responses to regulatory agencies.
- Participate in project meetings and support the Regulatory function.
- Bachelor's degree in a related technical field or equivalent education and applicable work experience.
- Regulatory Affairs Certificate, preferred.
- Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.
- 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 knowledge of medical device regulations in other international markets, including but not limited to Canada, UK, and Australia.
Tandem Diabetes Care offers a competitive compensation package, including bonus, equity, and a robust benefits package. 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 401(k) plan with company match.
We are an equal opportunity employer and maintain a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table.
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