Post Market Surveillance Specialist

Hologic • Marlborough, MA

12h • $54,900 - $70,500

About The Position

Responsible for receiving, reviewing, and processing product complaints for manufactured and distributed products as required by applicable regulations, standards, and company policy. This position combines skills in post market regulation, statistics, and product knowledge in the process of trending and handling incoming complaints. Partners with Product Support / Quality Engineering or other investigators on product investigations and trends. The Specialist 1 is provided direction from the Post Market Surveillance Manager to maintain the complaint processes and is in process of acquiring the job skills to complete these tasks.

Requirements

• Bachelor’s Degree required, preferably in a healthcare related field.
• Minimum 0 – 1 years of related experience in the healthcare/device industry or exposure to medical device quality system regulations understanding of drug/device safety requirements are required.
• Understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211).
• Knowledge based PC computer skills essential, such as industry recognized complaint management systems, MS Access and Excel.

Nice To Haves

• Prior experience processing medical device or drug complaints strongly preferred.
• Strong interpersonal skills.

Responsibilities

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues, including fulfillment, assay and instrument complaints.
• Assists with the review of complaints to determine potential adverse events.
• Assists with the preparing and submitting post market surveillance reporting including but not limited to Medical Device Reports and Adverse Events to the FDA within regulatory timeframes.
• Assists with the writing and approving vigilance reports/international regulatory submissions.
• Assists with complex investigations as required.
• Conducts timely and insightful response to investigations.
• Assists with the department metrics and works with others to ensure department goals are achieved.
• Assists with preparing agendas, facilitates cross functional meetings and creates meeting minutes.
• Assists with owners on determination of effective CAPA.
• Work with Technical Service or Field Service to ensure appropriate required information is documented in complaint.
• Works with other Post Market Surveillance personnel to ensure consistency in documenting complaints.
• Assist in external & internal audits.
• Assists with the customer communication (response letters, acknowledgement letters) as appropriate.
• Performs queries to provide complaint data and trend analysis on reported product problems/complaints.
• Strives to meet Accuracy Goals (95% accuracy goal). Ensures data is collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality.
• Creates or update QMS documents.
• Other duties as assigned.
• Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP).
• Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation.
• Actively contributes to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork.
• Engage in continuous improvement initiatives, striving for operational excellence and efficiency.
• Promote sustainable practices within the workplace, including waste reduction, recycling, and energy conservation.
• Participate as applicable in workshops, training sessions, and other activities aimed at fostering a culture of continuous improvement and lean thinking.
• Participate in regular training and complete all training on time.

Benefits

• comprehensive training when you join
• continued development and training throughout your career

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level