Medical Device Reporting Specialist at BIOTRONIK, Inc. in Lake Oswego, Oregon

Job Description:

Medical Device Reporting Specialist

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

BIOTRONIK is looking to add a Medical Device Reporting Specialist to our Regulatory team.  The Medical Device Reporting Specialist is responsible for executing activities associated with medical device complaints, including complaint processing, investigation, and reporting to FDA (when applicable). The Medical Device Specialist receives both implantable and non-implantable medical devices, and processes and reports them according to company procedures and FDA regulations.  Position is also responsible for corresponding with field representatives, customers, the manufacturer and the FDA to ensure compliance with applicable regulations.

Your Responsibilities

• Complaint investigation and reporting, including phone calls to company representatives, hospitals, physician’s offices, and competitors


• Consults with subject matter experts to make sound and accurate regulatory reporting decisions based on regulatory guidelines


• Correspondence of returned medical devices with manufacturer


• Facilitating correspondence between the manufacturer and field representatives, the FDA and other organizations


• Processing evaluation results of complaints supplied by the manufacturer and entering the data into our complaint system


• Preparing for internal and external audits


• Prepare and submit all MedWatch reports, both initial and follow-up reports to the FDA in compliance with regulations, guidelines and the required timeframe


• Take responsibility for maintain efficient Medical Device Report work flow and work assignments to achieve complete and timely closures


• Evaluate explanted (biohazard) medical devices and paperwork to make complaint determinations


• Updating department work instructions as needed, including proof reading and following the approval process until completion


• Drafting evaluation results letters for physicians


• Sharing highly regulated patient data with the clinical studies department, customer solutions and advance product support


• Work with the shipping department on receiving product with complaints associated and shipping out complaint product to the manufacturer


• Giving presentations to new employees regarding the complaint reporting process and the returned product process


• Other duties as assigned

Your Profile

• Excellent verbal and written communication skills


• Must be extremely detail oriented, reliable, self-motivated, organized, able to prioritize, patient, a team player and have the ability to follow procedural time-lines.  


• Must have excellent data entry skills


• Strong analytical skills (problem solving, critical thinking)


• Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.)


• Must be able to work in a fast-paced environment


• Must be able to adapt to change

Preferred Education and Experience

• Experience with complaint handling, MDR/Vigilance reporting


• Knowledge of 21 CFT Part 803, Medical Device Reporting


• Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA Statute

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Lake Oswego, OR | Working hours: Full-time  | Type of contract: Undefined 

Apply now under: www.biotronik.com/careers

Job ID: 35943  | Contact: Amanda Willott 

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