Morgan Gniewkowski
Regulatory Affairs Manager, Women\'s Health
- Role
- Manager, Regulatory, Women\'s Health at Bonafide Health
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
About Morgan Gniewkowski
Reliable Regulatory Professional and Health Enthusiast with 7+ years of experience in FDA…
Experience
Manager, Regulatory, Women\'s Health
Jun 2024 — Present · Harrison, NY, US
Oversees all regulatory affairs operations for dietary supplements, cosmetics, medical devices, OTC drugs, and combination devices(drugs/devices) across three women’s health brands- Manages structure/function claim submissions to FDA for all dietary supplement products- Updates and maintains cosmetic product listings to comply with MoCRA- Owns facility and product registrations for food, supplements, medical devices, and OTC drugs - Enhances claim substantiation and innovation project workflows by implementing SOPs and processes- Supports clinical trials as needed, providing input on IRB submissions and study design- Ensures compliance through meticulous review of product formulas, raw materials, and label artworkIntegral to 510(k) submissions for Class I & II medical devices(suppositories, lubricants, applicators, and test strips)- Guides product innovation teams on regulatory risks with a proactive, solution-oriented mindset- Presents quarterly updates to senior leadership team on relevant changes to the regulatory landscape regarding the FDA, FTC, and other regulatory bodies- Engages regularly with industry groups and attends conferences to expand regulatory knowledge and build connections with experts- Applies regulatory knowledge to review and approve documents such as labels, website pages, emails, social media content, blogs, and advertising- Supports launch of new and existing product SKUs into large commercial retailer stores- Fosters strong relationships with cross-functional business partners such as operations, quality, marketing, clinical research, and legal
Education
Freeport Area Senior High School
High School Diploma
Slippery Rock University
Bachelor of Science - BS, Biochemistry
2016 — 2019
Duquesne University
Pre-Pharmacy Studies
2015 — 2016
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