Sr Post Market Surveillance Specialist - Remote

Location of Work Remote, US

Employment Type Full Time Employee

Job Description

Our mission

At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.

Our brand promise

We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.

• Remarkable service A seamless, personal process designed around you and your needs.

• Trusted performance Our product family is the result of years of experience championing surgeons and listening to their expertise.

• Outstanding value No matter the surgical specialty, we deliver quality products for all markets.

Our people promise

Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.

Job Purpose Summary

As a Sr Post Market Surveillance Specialist, you will ensure customer complaints are reviewed, evaluated, investigated, documented and closed in a timely manner to ensure compliance with applicable Global Regulatory requirements.

What you will do

• Support all post market compliance activities including handling of customer complaints, adverse event reporting and medical device reports

• Perform preliminary investigation of complaints, including follow up with healthcare professionals

• Initiate, complete, and submit adverse event reports in an accurate and timely manner to the appropriate regulatory authorities within the required timeframe per applicable geography regulations.

• Use product and process knowledge to escalate complaints to the Engineering and Supply Chain teams for product support

• Compiles assigned complaint investigation and failure analysis information into an investigation report, documents root cause, applies event codes and routes complaint investigation reports for approvals per established timelines.

• Communicate effectively with internal and external customers on the outcome of complaints and adverse event investigations

• Drives complaints investigation, progress, reporting timeliness and determines closure

• Collaborates with Supply Chain, Engineering, Product Design, Commercial, and other support areas to obtain/provide information related to complaint investigations, customer feedback, and other aspects of complaint handling

• Applies knowledge of medical device regulatory requirements in order to support the MDR reporting process and identifying reportable events as they are received.

• Communicate effectively with internal and external customers on the outcome of complaints and adverse event investigations

• Keeps organization abreast of customer complaints and adverse events trends and escalates appropriately

• Participates in new hire training and continuous Regulatory Compliance training as required

• Participates in process improvement activities to continuously improve process effectiveness

What you will need (job requirements)

• Bachelor’s degree in Life Sciences/related field or equivalent work experience

• 5+ years of experience working in a medical device industry

• 1+ years or experience in managing, processing and closing product complaints

• Working knowledge and understanding of the FDA 21 CFR part 803 Medical Device Reporting and part 820.198 for Complaint File management

• Global regulatory medical device requirements for EU, MDSAP countries, and other related requirements.

• Ability to manage real-time customer feedback and process information to provide primary product support or resolve simple inquiries.

• Understands clinical settings enough to engage a conversation with clinicians related to product characteristics.

• Ability to analyze information and derive root cause or preliminary conclusions related to product perceived or confirmed failures.

• Firm understanding of regulatory reporting requirements for medical device reporting.

• Firm understanding of quality systems regulations, specifically good documentation practices.

• Fluent English and Spanish a must, other languages a plus.

What we value

• Customer First - We deliver extraordinary experiences.

• Accountability - We do what we say.

• Integrity - We do what is right.

• Inspired - We love what we do.

• One Global Team -We before me, always.

Join us today and Excel@Corza !

Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.

Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.