Post Market Surveillance Analyst II

Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 80 countries around the world.

“Leading the World with Innovative Healthcare Solutions that Enhance Lives”

Summary (Major Purpose of the Role):

The Post Market Surveillance Analyst II is responsible for supporting the complaint handling system through the timely assessment, processing, distribution of information, and communication of alleged product quality defects for all medical devices within the scope of Drive DeVilbiss Healthcare.

Main Activities/Responsibilities:

• Performs/Assists with Post Market Surveillance Analyst responsibilities.
• Support maintenance of a post-market surveillance system
• Assist as the subject matter expert on post-market surveillance for medical devices, ensuring support through activities related to decision-making, disposition, and closure of complaints
• Assists with projects impacting post-market functions and/or system
• Ensure complaints and adverse events requiring the attention of management are communicated
• Monitors KPI’s to ensure to ensure metrics are achieved and identifies problems and assists with solutions
• Provides support and assists with analysis of quality data and provides reporting, metric performance, and supporting information as required.
• Assist in maintaining and updating department procedures to reflect current regulatory requirements and department practices, and ensure they are followed
• Provide appropriate input to Corrective and Preventative Actions (CAPA) program and Management Review as well as post-market input to design and development teams
• Support product recalls and field safety corrective actions
• Provides support during external audits/inspections
• Support maintenance of a post-market surveillance system
• Additional duties as assigned

Competencies:

• Working knowledge of quality management systems with understanding of the Post Market Surveillance (PMS) requirements reflected in ISO 13485, Medical Device Single Audit Program (MDSAP), Medical Device Regulations (MDR), and the Quality System Regulation
• Subject matter expert for post-market surveillance in the medical device field with direct experience engaging external auditors/inspectors from regulatory authorities
• General understanding of quality records requirements and how they apply to complaint files and regulatory reports
• Make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

Reporting Relationships and Supervision:

• This position does not direct reports.

Education and Experience:

• Bachelor’s degree in a medical, biomedical, or relevant field
• Minimum three years’ experience in Quality Management in the medical device industry
• Experience with quality management and quality systems with knowledge and understanding of the Post Market Surveillance (PMS) requirements reflected in ISO 13485, Medical Device Regulations (MDR), and the Quality System Regulation
• Experience interfacing with competent authorities in charge of vigilance activities
• Advanced knowledge of applicable regulations and standards related to medical device reporting internationally
• Must demonstrate initiative, balanced assertiveness working as a team player
• Ability to cultivate a network of productive relationships in an international environment
• Excellent verbal and written communication skills in English
• Ability to manage multiple priorities
• Experience working in an environment with global objectives

Why Apply to Drive DeVilbiss…

Competitive Benefits, Paid Time Off, 401(k) Savings Plan

Pursuant to New York law, Drive DeVilbiss Healthcare provides a salary range in job advertisements. The salary range for this role is from $62,800.00 to $ 94,200.00 per year. Actual salaries may vary depending on factors such as the applicant’s experience, specialization, education, as well as the company’s requirements. The provided salary range does not include bonuses, incentives, differential pay, or other forms of compensation or benefits which may be offered to the applicant, if eligible according to the company’s policies.

“Drive DeVilbiss is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment. Drive DeVilbiss strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered person because of race, color, religion, gender, sexual orientation, gender identity, pregnancy and/or parental status, national origin, age, disability status, protected veteran status, genetic information (including family medical history), or any other characteristic protected by federal, state, or local law. Drive DeVilbiss complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.”