ISO 9001, SOC

2, or HIPAA Exposure to quality management systems, document control, or CAPA processes Familiarity with design controls, Design History Files, or a comparable engineering change-control discipline Nice to Have Working knowledge of ISO 13485 and FDA quality system requirements (21 CFR Part 820) Participation in an FDA 510(k) submission Experience hosting a regulatory audit or inspection Risk management under

ISO 14971

MDSAP, Health Canada, or TGA experience Software as a Medical Device experience, including

IEC 62304 EU MDR

technical documentation experience Greenlight Guru or another eQMS platform RAC, CQA, or CQE certification What You Get Paid Time Off. Accrues from Day 1, usable after 90 days. Doubles after your third year. 9 paid company holidays per year. Full-time gets 8 hrs paid per holiday. Your birthday off, paid. Completely separate from your regular PTO — it's a gift on top. Financial Benefits 401(k) with company match. 100% on the first 1% you contribute, then 50% on the next 5% — up to 3.5% of your pay in free retirement contributions. New in 2026. HRA — tax-free medical reimbursements. Pay a doctor's visit, prescription, or ER bill out of pocket, then submit it back to us to be reimbursed pre-tax. Tuition reimbursement up to $1,000/semester. Any class, any program, any field — finish a C or better and we cut you a check at the end of the semester. Employee referral bonus. $200 per successful hire. No cap. Working Advantage discount portal. Hotels, theme parks, rental cars, concerts, movies — typical savings of 10-40% off retail. Why This Role Is Worth Taking You will be the company's authority on quality and regulatory initiatives. You will interact directly with company leadership and you will develop a specialized, durable skill set in medical device regulatory affairs. If you are a strong program manager looking to advance your career, this is that step.

Pay:

$30.00 - $40.00 per hour

Benefits:

401(k) 401(k) matching Paid time off Parental leave Referral program Tuition reimbursement

Work Location:

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