Employer Industry: Diabetes Technology

Why consider this job opportunity:
- Salary up to $108,000 annually
- Competitive compensation package that includes bonuses and equity
- Fully remote position with provided equipment and virtual training
- Commitment to a diverse and inclusive workplace
- Opportunities for professional growth and development
- Supportive work environment that values employee well-being

What to Expect (Job Responsibilities):
- Prepare and maintain domestic and international regulatory filings to meet corporate objectives
- Develop and implement regulatory strategies for medical device approval and marketing primarily in the US and Canada
- Review promotional materials for compliance with regulatory standards
- Support regulatory intelligence function by tracking updates to standards and regulations globally
- Participate in product development core teams as the regulatory representative

What is Required (Qualifications):
- Minimum of 5 years of Regulatory Affairs / Quality Assurance experience within an FDA-regulated medical device industry
- Demonstrated knowledge of medical device regulations in the US and Canada
- Proficient knowledge of quality standards: ISO 13485, 21 CFR Part 820, and other industry standards
- Bachelor's degree in a related technical field or equivalent education and applicable work experience
- Excellent technical writing, editing, and proofreading skills

How to Stand Out (Preferred Qualifications):
- Regulatory Affairs Certificate preferred
- Certification (RAC) by the Regulatory Affairs Professional Society or documented training in medical device regulations
- Experience with Diabetes insulin pumps is a plus
- Familiarity with document management systems and electronic Submission Template And Resource (eSTAR)
- Experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare is a plus

#DiabetesTechnology #RegulatoryAffairs #RemoteWork #CareerGrowth #InclusiveWorkplace

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