Clinical QA Specialist

Are you passionate about ensuring the highest standards of quality and compliance in the medical device industry? We are seeking a dedicated and dynamic Post Market Clinical Specialist to join our team onsite in Newark, DE! In this pivotal role, you will be responsible for the timely and thorough investigation and reporting of Potential Adverse Events, Adverse Events, and other regulatory reporting required due to complaints analysis. You will work closely with Technical Service, Marketing, Sales, Legal, and potentially Customers, fostering seamless communication and collaboration. This role requires your presence onsite, allowing you to make a tangible impact and drive excellence in our operations. Apply today!

Responsibilities 

• Event Assessment and Reporting: Assess Potential Adverse Events as per corresponding regulations and procedures. Submit Adverse Events/Serious Injuries and follow-up reports in accordance with applicable procedures and in a timely manner.
• Follow-Up Coordination: Follow up with end users and any internal department (such as Tech Support) for additional information related to Adverse Event/Serious Injuries reporting. Ensure Good Faith Efforts made to customers are completed and documented in a timely manner within Hologic’s QMS.
• Regulatory Submissions: Submit Adverse Events/Serious Injuries reports when a MedWatch or any other notification is received (from Notified Bodies, Regulatory Agencies, and other sources such as PSURs). Ensure customer communications are created and issued in a timely manner.
• Collaboration with Technical Teams: Work with Technical Service and/or Field Service to ensure appropriate required information is documented in complaints related to adverse events. Ensure metrics and indicators related to adverse events/serious injuries reporting are under control.
• Regulatory Agency Responses: Lead or provide support to any response to Regulatory Agencies when follow-up questions are submitted to Hologic.
• Risk and Health Assessments: Support Risk and Health Assessments. Participate in Internal and External Audits/Inspections and Assessments.
• Investigation Supervision: Execute and/or supervise investigations such as NCEs, CAPAs, IACAs, and/or similar. Ensure they are performed on time, in compliance with procedures and regulations, and drive to resolution to eliminate compliance concerns.
• Process Innovation: Innovate processes to improve efficiency and ensure compliance with Post Market Surveillance’s requirements. Support, develop, control, and analyze best-in-class metrics and quality reports related to Reportable Events.

Qualifications

Education     

• Bachelor's degree in Medicine, Nursing, and Biomedical/Electromedical Engineering. Risk Managers can also be considered. 

Experience   

• 5 plus years’ experience supporting fillings and submission of MDR's 

Skills

• Experienced with FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14970, Risk Management 
• Must possess the ability to work independently to collect information associated with event, understand the actual and potential outcomes of event, and appropriately assess next steps related to the event.       
• Must be able to communicate effectively with both internal team, sales team, customers, patients, and regulatory agencies. 
• Must be able to understand medical procedures related to portfolio of products and expected and potential outcomes related to impact to patient.   
• Thrives in a fast-paced, collaborative environment

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $83,000 - $129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

LI-#DS1