Requisition ID: 7354

Job Title: Senior Post-Market Surveillance Analyst

Job Country: United States (US)

Here at Avanos Medical, we passionately believe in three things:

• Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
• Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
• Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. 

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. For more information, visit www.avanos.com.

The Role

Working under the direction of the Global Post Market Surveillance Management, this position serves as the lead Post Market Surveillance Analyst. This position is responsible for Domestic and International Health Authority Reporting to Regulatory Agencies.

This position includes the reportability of customer complaints, compliance with regulations, guidelines, and ensuring on time reporting for the United States, Canada, and EMEA (EU MDR), as well as working with regional partners to ensure on-time reporting in Japan, Asia Pacific, South America, Latin America, and any other regions and regulations where applicable.

This position has oversight of the Global Post Market Surveillance day-to-day guidance, trouble-shooting, regulatory follow-up and support.

This position also applies computerized quantitative and analytical methods to interpret complaint trends and generates periodic management reports related to those analyses. In addition, position maintains and implements changes to existing compliance-management software.

Responsibilities

• Monitor potential reportability decision making by Intake team regarding reportability of customer complaints for the appropriate Global Regulatory Agencies, including but not limited to FDA, EMEA (Europe, Middle East and Africa) vigilance (EU MDR), Canada, and other appropriate regional regulations and guidelines.
• Review potential reportable events for responsible Global regions and make decisions on whether to report to the Global Regulatory Agencies, while working with clinical personnel on medical evaluations.
• Complete documentation and submit reportable events to the Global Regulatory Agencies within required timelines including but not limited to: FDA Medwatch Reports, Manufacturer Incident Reports for EMEA (EU MDR), Medical Device Product Reports for Health Canada, etc
• Work with CHU (Complaint Handling Unit) team to ensure accuracy in complaint reporting
• Perform Tracking and Trending of Potentially Reportable Events.
• Oversee activities of complaint handling including trouble-shooting and providing data base system support.
• Provide training as needed on Global Post Market Surveillance systems and processes.
• Manage high risk complaint escalation process.
• Review and understand metrics, periodic reports, and data processing strategies related to customer complaints and contacts. Makes use of all available data to identify potential risks with our products, and/or opportunities for improvement within our processes. Responsible for engaging all proper functional groups when a plan is necessary to address an identified high risk-analysis situation.
• Establish and maintain strong relationships with manufacturing sites to enforce good investigations and to ensure that adequate corrective actions are being implemented in a timely manner, escalating appropriately for senior management involvement.
• Establish and maintain good relationships with the Global Regulatory Agencies as required with respect to providing on time and accurate reporting according to regional requirements based on established metrics, including but not limited to responding to complaint related inquiries and requests.
• Works collaboratively with Product Supply, R&E, Quality, and other departments, as required with respect to failure analysis investigation, assessing appropriateness of investigations and corrective actions and driving completion in a timely manner based on established metrics.
• Actively participates and provides audit support during internal and external audits.
• Monitors for changes in regulatory agency requirements for changes and updates policy and procedures accordingly.
• Performs quantitative reports analysis for global regulatory agencies, including but not limited to Periodic Summary Report (PSR), FDA Maude Database Review and searches, and complaint Key Word searches.
• Leverages clinical background and knowledge to appropriately determine International Medical Device Regulators Forum (IMDRF) coding for all reportable complaints.
• Actively participates in Employee Resource Group (ERG) activities.
• Supports Field Actions related to adverse event reporting based on established metrics.
• Regularly updates reportability strategy based on input from Medical Reviewer, Medical Director, and leadership.
• Clinically supporting external customers and manufacturing sites via medical device training, adverse event training, and general medical device Q&A.

Job Specific Responsibilities:

• Provide expertise in complaint system database application, maintenance, and expansion of functionality
• Provide analytical expertise as it relates to complaints, trends, and data from manufacturing locations.
• Keeps management aware and escalates emerging issues related to products, human resources, communications, or processes.

Qualifications

Required:

• B.S. or B.A. in a related field
• 7+ years in the Healthcare, Medical Device, Pharmaceutical industry or equivalent M.S. or M.A. in a related field or equivalent Registered Nurse (R.N.)
• Experience with complaint handling systems
• A fundamental working knowledge of ISO, FDA, cGMP, EU MDR, MDSAP, EUDAMED, Health Canada regulations at a minimum
• Strong oral and written communication, analytical skills, and organizational skills
• Strong Microsoft Office skills (Word, Excel, One Note, Power Point)

• Position will be based in Alpharetta and and expected to work in the office Tuesday – Thursday and as required for meetings, training, and audits. 

Preferred Qualifications

• EtQ Reliance Complaint Handling Software
• Some training in statistics is desirable

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

IMPORTANT: If you are a current employee of Avanos or a current Avanos Contractor, please apply here.

Join us at Avanos
Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.

Make your career count
Our commitment to improving the health and wellbeing of others begins with our employees – through a comprehensive and competitive range of benefits. We provide more than just a salary – our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.

Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.

Avanos also offers the following:

benefits on day 1

free onsite gym

onsite cafeteria

HQ region voted 'best place to live' by USA Today

uncapped sales commissions