Regulatory Affairs Lead – Drug-Device Combos (Hybrid)

Qnovia, Inc.; Newport Beach (CA); Hybrid; USD 120,000 - 155,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision insurance

Equity ownership in a pre-commercial stage company

Flexible hybrid work arrangement

401(k) with company match

Job summary

Qnovia, Inc. in Newport Beach is seeking a Regulatory Affairs Specialist to lead regulatory strategy for drug-device combination products. You will develop and execute regulatory strategies, prepare submissions, and liaise with regulatory agencies such as the FDA and MHRA.

The ideal candidate has 5+ years of experience in regulatory affairs, a Bachelor's degree in a related field, and strong technical writing skills. Compensation ranges from $120,000 to $155,000 annually, including equity participation.

We offer comprehensive medical insurance and a flexible hybrid work arrangement.

Qualifications

• 5+ years of regulatory affairs experience in the pharmaceutical or medical device industry.
• Direct experience with FDA CDER and/or CDRH submission processes.
• Knowledge of 21 CFR Parts 210, 211, 314, 812, and 820.

Responsibilities

• Develop and execute regulatory strategies for drug-device combination products.
• Prepare and manage IND, NDA, 505(b)(2), and MAA submissions.
• Author and review regulatory documents including briefing packages.

Skills

Regulatory affairs experience

Technical writing and document management

Knowledge of FDA CDER processes

Knowledge of CDRH submission processes

Experience with combination product pathways

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Job description

Qnovia, Inc. in Newport Beach is seeking a Regulatory Affairs Specialist to lead regulatory strategy for drug-device combination products. You will develop and execute regulatory strategies, prepare submissions, and liaise with regulatory agencies such as the FDA and MHRA.

The ideal candidate has 5+ years of experience in regulatory affairs, a Bachelor's degree in a related field, and strong technical writing skills. Compensation ranges from $120,000 to $155,000 annually, including equity participation.

We offer comprehensive medical insurance and a flexible hybrid work arrangement.