Senior Post Market Surveillance Analyst

Senior Post Market Surveillance Analyst

Location : Minneapolis, MN, US

Job Family : Quality Assurance

Country / Region : United States

This position is essential to the compliance of the company with FDA and international regulatory authorities. This position is responsible for supporting the post market surveillance activities for Interventional Urology (IU) Business Unit.

Major Areas of Accountability :

• Responsible for creating and maintaining Post Market Surveillance plans and reports with cross functional team for the IU Business Unit in accordance with applicable regulations (i.e. EU 2017 / 745)
• Compile and analyze complaint data for reports such as Clinical Evaluation Report (CER) or country submissions
• Complete trend review analysis for EU 2017 / 745 and present outcome to a cross functional team for a reporting decision
• Alert Quality Management of unusual trends during post market activities and coordinate cross functional input as needed
• Contribute to the development and optimization of methods and procedures for effective post market activities and trending
• Support monthly Product Review presentations as required
• Support internal and external audits as required
• Support complaint intake as required
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
• Other job duties as assigned.

Basic Qualifications :

Knowledge, Skills & Abilities :

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect :

Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the worlds leading medical device companies. We are constantly growing our business and always looking for new ways to move forward we explore, learn and look for new ways of doing things.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

59835 #LI-CO #LI-HYBRID

Nearest Major Market : Minneapolis