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Becton Dickinson

Global medical devices, lab equipment supplier

Associate Director Field Assurance

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeWarwick, RI, USANo salary listed

About the Job

Requirements

  • A B.S. degree in Engineering, Science, Biology, Business Administration, or an equivalent degree is required; an advanced degree is preferred.
  • At least 5 years of related experience managing complaint handling in the medical device, pharmaceutical, or biotech industry.
  • Supervisory or management experience is required.
  • Strong working knowledge of medical device terminology and anatomical and physiological terminology is required.
  • Strong working knowledge of the medical device industry and regulatory requirements is required.
  • Proficiency in Microsoft Office applications, including Excel, Word, and Outlook, is required.
  • Strong written and verbal communication, presentation, problem-solving, and applied-thinking skills are required.

Responsibilities

  • Lead and manage Field Assurance resources and activities within the Quality Assurance function.
  • Lead and supervise complaint handling and medical device reporting processes across the Surgery Business Unit to ensure timeliness, consistency, and compliance with internal standards and procedures and applicable external industry regulations and standards.
  • Lead business-unit and corporate-wide continuous-improvement initiatives for complaint handling.
  • Escalate significant events, trends, potential quality issues, and personnel issues as needed to ensure actions address operational and product-performance quality issues.
  • Provide guidance and training to staff, drive organizational development, assist staff in attaining career goals, and motivate individuals to achieve results.
  • Manage staff performance and provide fair, accurate, and timely feedback.
  • Manage and present analysis of complaint-handling operations and product performance in management and post-market surveillance reviews.
  • Provide complaint-handling and regulatory-reporting subject-matter expertise in support of internal and external audits.
  • Serve as a liaison between the company and regulatory agencies for audits and additional-information requests, as needed.
  • Ensure personal and staff training is completed by established due dates and maintain the staff training matrix.
  • Maintain and adhere to departmental processes and systems to ensure regulatory compliance.
  • Support and manage the annual budget for areas of responsibility.

Desired Qualifications

  • An advanced degree is preferred.

About the Company

Becton Dickinson

Global medical devices, lab equipment supplier

BD (Becton, Dickinson and Company) is a global medical technology company that designs, manufactures, and sells medical devices, laboratory equipment, and related services for hospitals, labs, clinicians, and biopharma partners. It operates in four segments: Medical Essentials (medication delivery and specimen management devices), Connected Care (medication management and advanced patient monitoring systems), BioPharma Systems (drug delivery systems for pharmaceutical partners), and Interventional (surgical, endovascular, urological, and critical care products). In addition to devices, BD offers connected software, analytics, clinical education, customer portals, and service programs to support its products. The company’s goal is to help healthcare providers improve patient outcomes by enabling safer and more efficient delivery of care through integrated devices, data, and services across the health ecosystem.

Company size
10,001+
Company stage
IPO
Headquarters
Franklin Lakes, NJ
Founded
1961

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