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.
...assistant, or similar role (law firm experience is a plus). Excellent communication and interpersonal skills. Strong organizational abilities and attention to detail. Proficiency in Microsoft Office Suite (Word, Excel, Outlook). Ability to multitask and...
...The UI/UX Designer position will create and design user-centered designs for digital products, such as applications, websites, and software... ...while remaining focused on service to the client; ~ Manage time effectively to meet deadlines; ~ Ability to adapt to...
...systems and processes. Work Environment Hybrid schedule: MondayThursday in-Downtown Austin office (8 AM5 PM), Friday remote, one remote Saturday half-day/month. Collaborative team setting with cross-training opportunities. No direct customer contact...
...County, IL. This is an in-office full-time role, supporting the sales team. Help us serve our clients, where together... ...success in this position: A general understand of the high-end construction... .... Benefits: If you want to grow this is a stellar career growth...
...Overview: We are seeking a dynamic and organized Receptionist/Office Assistant to join our team. The ideal candidate will have a strong background... ...and a service-oriented attitude Strong organization and time management skills Collaborative, team-player mentality...