Global Compliance Vigilance Lead - Medical Devices

Job Description

A collective energy and ambition. A place where you can make a real difference.

We’re a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

Responsible for the oversight and vigilance of an assigned product category. Monitors market feedback for the identification of emerging trends or potential safety/efficacy signals. Collates and analyzes data monthly and presents to the wider business. Delivers the required regulatory outputs from the Global Vigilance system as per determined deadlines.

Role Accountabilities and Responsibilities   (Describe the 5-7 major accountabilities)                                                       

• Analyzes the data from the vigilance system to identify emerging areas of concern, driving timely feedback to the business.
• Responsible for monitoring, analyzing and applying trending methodologies to the vigilance data submitted to Health Authorities (e.g MDRs/MIRs).
• Compiles, analyses and required reports of post-production information as part of the vigilance system (PSURs, PMS Reports, as applicable).
• Delivers monthly product classification vigilance reports to the business, presenting key information/trends to a cross functional audience.
• Identifies emerging signals as to the safety and efficacy of our products, and drives inputs into other aspects of the Church & Dwight Quality Management System (QMS) including but not limited to production, risk management, labelling and product development.
• Functions as SME (subject matter expert) for vigilance activities during CAPA’s, internal and external audits.

Education and Experience                                                           

• Bachelor’s degree from accredited institution (Science, Bio-medical preferred)
• 3+ years’ experience with Medical Devices (ISO 13485, MDSAP, MDD, EUMDR), or Pharmacovigilance requirements preferred.
• 3+ Experience with complaint handling processes preferred.

Skills and Competencies

• Ability to complete daily/monthly tasks as assigned to ensure timely delivery of outputs.
• Able to follow requirements of SOP, WI, or documented decision trees.
• Able to deliver required regulatory outputs in a prioritized manner.
• Able to balance multiple priorities to ensure the requirements of the complaint handling system are met in a timely manner.

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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/