RA/QA Manager PAPR / NIOSH Respiratory Protection Systems

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 - $100,000.00 per year

Benefits:

Health insurance Application Question(s): Do you have direct experience with

NIOSH TC

approval submissions or maintenance? Do you have experience with PAPR products? Please briefly describe your experience with

NIOSH TC

approvals, or PAPR systems.

Experience:

PAPR/NIOSH

1 year (Required)

Work Location:

In person