Manager - Post Market Quality (Kennesaw, GA)

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview:

The Manager of Post Market Quality will manage and maintain the Postmarket Surveillance (PMS) Program, including Complaint Handling, Adverse Event Reporting, Customer Feedback, Field Actions, and Health Risk Assessment. Will ensure compliance to U.S. and international regulations regarding the reporting of adverse events and product complaints.

Responsibilities:

• Maintain compliance for the regulatory requirements relating to Complaint Handling, Adverse Event Reporting, including management of staff and resources assigned to handle these activities.
• Manage the Post-Market Surveillance Program. This includes timely compilation of all Post Market Surveillance Plans and Reports for all products manufactured by the Kennesaw and Austin facilities.
• Oversee the generation and assure appropriate distribution of Post-Market Surveillance track and trend data. Assure management is made aware of potential trends in a timely manner.
• Manage recall activities. Assure timely regulatory reporting of recall activities.
• Manage the generation and distribution of field safety notices.
• Manage the Customer Feedback program.
• Manage the activity of and develop the skills of the staff for Field Assurance.
• Design workflows and implement processes and procedures to ensure timely completion of reports and compliance in areas of responsibility.
• Conduct final review of complaint files, including but not limited to complaint summaries, coding incidents for appropriate conclusions and external/interdepartmental reports.
• Ensure MDR (Medical Device Reporting) forms, Canadian, Australian, and Tier II country, or applicable country adverse events forms are submitted in a timely manner.
• Recognize, evaluate and interpret complaint trends, will participate on design review teams/product and process improvement teams, and provide interactive feedback for improved safety, usability and labeling.
• Liaise with Clinical Affairs, Quality Systems, Regulatory Affairs and other departments as necessary to ensure appropriate monitoring of post market data.
• Participate in regulatory inspections and internal/external audits as appropriate.
• Ensure interface throughout the product realization process and during the entire product life cycle including post market-surveillance.
• Perform/coordinate in-depth investigations to include, where possible, root cause analysis for situations identified to be product complaints.
• Be knowledgeable on all applicable standards, regulations and procedures related to tissues and devices, both internally and externally.
• Keep informed and communicate significant changes/updates to regulations regarding the handling and investigation of complaints, adverse event reporting.

Qualifications:

• Bachelor's Degree, preferably in the Life Science or engineering field.
• Minimum of 5 years' experience in an FDA regulatory industry with knowledge of ISO, FDA, the Quality System Regulations, MDD, MDR(EU) 2017/745.
• Must be able to maintain a high energy level and be able to prioritize, manage and follow up on numerous projects.
• Effective communication skills, both oral and written. Ability to communicate and interface with people at all levels.
• Must be detailed orientated and exhibit a high degree of flexibility and initiative.
• Must have a strong understanding of human physiology and surgical protocols relating to the use of Artivion products.
• Will require up to 10% travel.
• This is a hybrid position based out of our Corporate HQ in Kennesaw, GA. Candidate must be willing to commute to Kennesaw 2-3 days per week.