Job Title: Director of Regulatory Affairs and Quality
Department: Product
Reports to: CEO
Position Type: Full Time Non-Exempt
PRIORITY RESPONSIBILITY
We are seeking an experienced Regulatory Affairs and Quality Manager with expertise in ISO 13485 to lead and manage our regulatory compliance and quality management systems. The ideal candidate will play a pivotal role in ensuring product compliance with applicable regulations and standards, managing audits, and driving continuous improvement initiatives. This position involves collaboration across teams to support product development, manufacturing, and market access activities globally.
We prefer candidates in the Bozeman, MT or Las Vegas/Henderson, NV area. We would also be open to remote positions.
ESSENTIAL DUTIES
Compliance & Submissions:
Communication:
Risk Management:
Misc cross functional assignments such as project management, marketing support and operational tasks.
Quality Management:
ISO 13485 Oversight:
CAPA Management:
Supplier & Manufacturing Quality:
Documentation & Training:
QUALIFICATIONS
Education:
Experience:
Skills:
Certifications (Preferred):
INTERESTED?
If you are interested in a challenging and rewarding position with an exciting company, please send your resume and letter of interest to [email protected]. Please note any prospects will be contacted from a goldenhelix.com domain email address.
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