Employer Industry: Diabetes Technology

Why consider this job opportunity:
- Salary up to $108,000 annually
- Competitive compensation package that includes bonuses, equity, and a robust benefits package
- Health care benefits available from day one, including medical, dental, and vision
- Minimum of 20 days of paid time off and 11 paid holidays per year
- 401k plan with company match and Employee Stock Purchase plan
- Supportive and innovative company culture that promotes employee well-being and growth

What to Expect (Job Responsibilities):
- Prepare and maintain domestic and international regulatory filings related to FDA and QSR compliance
- Support the preparation of international premarket submissions and US regulatory submissions for new product introductions
- Collaborate with regulatory leadership to evaluate product classifications and submission applications
- Manage regulatory submission files and participate in product development core teams
- Review promotional and marketing materials for compliance with regulatory standards

What is Required (Qualifications):
- Bachelor's degree in a related technical field or equivalent education and applicable work experience
- Minimum of 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 global submissions
- Knowledge of medical device regulations in international markets, including Canada, UK, and Australia
- Proficient knowledge of quality standards such as ISO 13485 and 21 CFR Part 820

How to Stand Out (Preferred Qualifications):
- Regulatory Affairs Certificate or Certification (RAC) by the Regulatory Affairs Professional Society
- Experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare
- Previous participation in creation of a Global Regulatory Strategy
- Familiarity with IEC 60601-series standards, specifically IEC 62304
- Excellent technical writing, editing, and proofreading skills

#DiabetesTechnology #RegulatoryAffairs #QualityAssurance #CareerOpportunity #InnovativeCulture

We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.