Prestige Ameritech is seeking an experienced Regulatory Affairs / Quality professional to lead and support regulatory and quality activities for our expanding Powered Air Purifying Respirator (PAPR) product line.
This is NOT a general quality role. We are specifically seeking candidates with experience in PAPR systems, NIOSH-certified products, and TC approval/submission processes.
REQUIRED EXPERIENCE
- PAPR and/or respiratory protection product experience
- Familiarity with NIOSH TC approval submissions and maintenance
- Experience supporting regulated product quality systems
- Experience with change control, documentation, and product configuration management
- Ability to work cross-functionally with operations, manufacturing, engineering, and leadership teams
STRONGLY PREFERRED
- Prior experience with:
- Honeywell
- 3M
- MSA Safety
- Bullard
- Other respiratory protection or industrial safety manufacturers
- Familiarity with:
- NIOSH respiratory approvals
- TC numbers and configuration management
- FDA and/or ISO 13485 quality systems
- CAPA and validation activities
- Product labeling and regulatory documentation
POSITION SUMMARY
This role will support the continued growth and regulatory compliance of a domestic respiratory protection manufacturing operation. The position requires a hands-on individual comfortable operating within a manufacturing environment while supporting quality systems, regulatory submissions, product compliance, and ongoing NIOSH requirements.
Candidates without respiratory protection or NIOSH-related experience are unlikely to be a fit for this role.
Pay: $80,000.00 - $120,000.00 per year
Benefits:
Application Question(s):
- Do you have direct experience with NIOSH TC approval submissions or maintenance?
- Please briefly describe your experience with NIOSH TC approvals, or PAPR systems.
- Do you have quality/engineering/manufacturing experience with PAPR products?
Experience:
- PAPR/NIOSH: 1 year (Required)
Work Location: In person
