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 equipment provided and virtual training
- Opportunity to work with a company that values innovation and personal connection to its mission
- Collaborative and inclusive work environment that supports 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
- Review promotional materials for compliance with regulatory standards
- Support regulatory intelligence by tracking updates to global standards and regulations
- Participate in product development core teams and coordinate project meetings

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):
- Experience with Diabetes insulin pumps
- Regulatory Affairs Certificate preferred
- Certification (RAC) by the Regulatory Affairs Professional Society or other documented training in medical device regulations
- Previous participation in creating a Global Regulatory Strategy in product development
- Experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare a plus

#DiabetesTechnology #RegulatoryAffairs #RemoteWork #CareerOpportunity #InclusiveWorkplace

"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."