Senior Regulatory Specialist, Product

6 days ago

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Church & Dwight Co., Inc.

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Consumer Products Manufacturing Company and Specialty Products Manufacturing Company

5001 - 10000

Description

• Oversees the regulatory needs of all WaterPik branded products in the US and Canada • Functions largely independently, yet cross-functionally with collaboration with R&D, Compliance, Quality, Manufacturing, Marketing, and Supply Chain. • Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, and De Novo submissions • Act as liaison with FDA regarding product submissions • Prepare robust non-filing justifications for changes that do not require a 510(k) submission • Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking • Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies • Monitor, interpret and communicate existing and new regulatory requirements for medical devices in US/Canada • Act as the primary regulatory point of contact during third-party audits

Requirements

• Bachelors degree from an accredited institution in a related field, ideally engineering sciences • 5+ years of professional experience in a regulatory environment • Practical understanding, interpretation, and application of FDA 21CFR 820, ISO13485, MDSAP, EU MDR, Medical Devices Regulations (SOR/98-282) or other quality standards for medical devices. • Occasional Travel 5% - 10% for onsite third-party regulatory audits

Benefits

• Medical, Dental, Vision Insurance / Healthcare and Dependent Care • Flexible Spending / Health Savings Account / Commuter Reimbursement Account • Vacation / Holiday / Sick Time / Pandemic Leave • Short and Long Term Disability • Life & AD&D / Spouse/Child Optional Life / Supplemental Life & AD&D • Family and Medical Leave / Bereavement • Adoption Assistance / Tuition Reimbursement • Employee Assistance Program • Identity Theft Protection • Critical Illness Insurance • Savings and Profit Sharing Plan / 401(k) Match / Employee Stock Purchase Plan