Regulatory Affairs Specialist II
4 days ago
We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet corporate objectives.
Key Responsibilities- Supports Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories.
- Fosters collaboration with key functional groups in Quality, Engineering, Marketing, Product Development, Manufacturing and Clinical Operations to educate and gain alignment of global regulatory 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.
- 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.
- Bachelor's degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics, or equivalent combination of education and applicable job experience.
- Master's degree or Regulatory Affairs Certificate preferred.
- Experience supporting manufacturing operations.
- 2+ years of experience working in an FDA regulated industry.
- Demonstrated experience with medical device life cycle and change management.
Tandem offers a competitive compensation package that includes 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 401k 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. If you're a motivated and detail-oriented individual who is passionate about regulatory affairs, we encourage you to apply.
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