Regulatory/Complaint Specialist

ABIOMED is a leading provider of circulatory support medical devices that offer a continuum of care to acute heart failure (heart attack) patients.  This is a unique opportunity to join a reputable, well-capitalized, growing company that has the exciting feel of a "start-up company" as we bring new technologies to the Cath Lab and the Cardiac Surgery suite.  ABIOMED is the developer of the world’s only fully implantable FDA-approved artificial heart, and the world’s smallest catheter-based Ventricular Assist Device.

 

ABIOMED is looking for a Regulatory/Complaint Specialist who will be responsible for the administration of  all complaints and regulatory decisions associated with ABIOMED products.

 

Principle Duties and Responsibilities:

 Ensure compliance to U.S. and International medical device complaint reporting requirements. Receive, enter and process customer complaints for all Abiomed product lines.  Assess each for reporting requirements. Complete and submit MDRs and follow-up reports to FDA and International Regulatory bodies within required time limits. Produce periodic trends and reports on field quality issues. Maintain complaint and MDR file documentation in accordance with applicable regulations. Provide training to field employees on MDR, Complaint Handling and applicable global regulatory requirements. Coordinate Recalls and Corrections/Removals and generate necessary reports and communications. Coordinate customer correspondence in response to complaints and product recalls. Maintain awareness and knowledge of domestic and international complaint handling and reporting regulations and changes to the regulations.

Job Qualifications:

 BA/BS required preferably in Life Sciences . 3-5 years experience in the medical device industry with minimum of 2 years experience handling complaints, investigation and/or MDR/MDV reporting required. Excellent interpersonal, analytical, verbal and written communication skills. Ability to function independently and effectively in a fast-paced, high volume environment. Strong computer and database management. Solid judgment and problem solving skills. Demonstrated leadership in process improvement initiatives is a plus.

Located in Danvers, MA, conveniently located off of Route 128, and with operations in Europe, we are looking for motivated leaders who share our mission of Recovering Hearts and Saving Lives TM while leading the industry in technology and innovation.  ABIOMED is the place to prove your ability to deliver results and join a world class team!

 

Click the following link to apply online:

https://www.hirebridge.com/application/appchoice.asp?jid=58814