Senior Regulatory Specialist, Product

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Job location: Remote, USA
 

The WaterPik Senior Regulatory Specialist oversees the regulatory needs of all WaterPik branded products in the US and Canada as well as a subset of Church and Dwight’s sister brands. Additionally, this role will serve as a guiding Center of Excellence (COE) for regulatory teams supporting the WaterPik and sister brands internationally.

Specifically, this role performs regulatory analyses and produces recommendations. Ultimately sharing with broader teams to inform project and product decision. This role functions largely independently, yet cross-functionally with collaboration with R&D, Compliance, Quality, Manufacturing, Marketing, and Supply Chain, among others.  At times, this role may partner with additional regulatory team members based on project size or scope. 

Role Accountabilities and Responsibilities                                                 

• Oversee all US and Canada regulatory needs for all WaterPik brands and US regulatory needs for other assigned Church & Dwight’s sister Brands.

• Serves as the Center of Excellence (COE) regulatory lead for all WaterPik brands and assigned C&D brands. 

• Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.

• Assess necessity for submitting a 510(k) application for proposed device modifications. Prepare robust non-filing justifications (note to files) 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 of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).

• Coordinate and prepare technical files for submission to Health Canada for timely licensing of new and modified medical devices, ensuring compliance with Canadian Medical Devices Regulations (CMDR) and guidance documents.

• Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to stakeholders.

• Collaborates closely with international regulatory associates to support the registration of WaterPik devices worldwide.

• Ensures FDA device listings and annual facility registrations are maintained.

• Create, guide, and advise on internal labeling guidance and policies, including product labels, Unique Device Identification (UDI), Instructions for Use (IFUs) and promotional materials.

• Monitor, interpret and communicate existing and new regulatory requirements for medical devices in US/Canada.

• Contribute and support continuous improvements to the end-to-end labeling and change control processes including policies, procedures, quality, and system tools.

• Support Quality needs for audit readiness for internal quality audits and external audits (e.g., FDA, EU Notified Bodies, MDSAP) by reviewing regulatory compliance.

• Act as the primary regulatory point of contact during third-party audits (FDA inspections, Notified Body audits, MDSAP audits), providing necessary documentation and clarifications.

• Review and maintenance of regulatory procedures and processes.

• Other duties as assigned by Regulatory Manager and higher.

Operating Knowledge, Skills, and Abilities                                                       

• Knowledge of medical devices regulatory policies, procedures and metrics

• Standard computer-based software knowledge

• Keeps accurate documentation and submits detailed reports

• High attention to detail, organization and accuracy

• Executes relevant policies and procedures

• Well organized and demonstrates forward leaning and high initiative

• Delivers project tasks on time

• Works cross-functionally to identify and communicate regulatory requirements

• Tests, confirms and/or improves processes

• Solves issues quickly and efficiently

• Ability to prioritize and handle multiple projects simultaneously

• Strategic and creative problem-solving skills

• Strong analytical skills

• Good oral and written communication skills

• Team minded, detail-oriented, proactive self-starter

Education and Experience                                                          

• Bachelors degree from an accredited institution in a related field, ideally engineering sciences.

• 5+ years of professional experience in a regulatory environment

• Specialist knowledge/expertise: medical or electromechanical devices

Required Training

• 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.

Other Requirements                                                        

• Occasional Travel 5% - 10% for onsite third-party regulatory audits

Salary and Benefits

WaterPik, Inc., a partner company of Church & Dwight Company, Inc., offers an extensive Total Reward package for this position, including:

Estimated pay:  $88,000 - $137,500 Salary

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

This information is provided in compliance with the Colorado Equal Pay for Equal Work Act and is the company's good faith and reasonable estimate of the compensation range and benefits offered for this position.  The compensation offered to the successful applicant may vary based on factors including experience, skills, education, location, and other job-related reasons.

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Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.

For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/