Senior Post Complaint Specialist Job in Boston, Massachusetts US

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COMPANY INFO

Our client company is looking for a Senior Post Market Complaints Specialist which is a key position within the company.  They will be responsible for the administration of all complaints and regulatory reporting decisions with all products. The company focus is on cutting edge cardiac recovery devices designed to assist or replace the pumping function in heart failure cases.

 

They manufacture catheter-based devices that provide cardiac circulatory support and have rapid and simple insertion; the devices are minimally invasive and are designed to enable the heart to rest, heal and recover by improving blood flow and circulatory support.  The company is focused in developing new ways to treat heart failure so that patients and physicians have the most advanced, successful, and beneficial technology available to improve quality of life.

 

JOB DESCRIPTION

·         Maintain Complaint MDR file documentation in accordance with applicable global regulatory requirements.

·         Ensure compliance to U.S. International medical device reporting requirements.

·         Receive, enter process customer complaints for all product lines and assess each for regulatory reporting requirements

·         Complete submit MDR’s and follow up reports to FDA International Regulatory bodies within required timeframes

·         Conduct follow up interviews with the Field Team /or external customers to gain information needed to make reporting decisions

·         Produce periodic trends and reports on field quality issues

·         Maintain professional customer correspondence in response to complaints

·         Maintain awareness knowledge of domestic International complaint handling and reporting regulations and changes to the regulations

                                                                        

QUALIFICATIONS

·         BA/BS required in Life Sciences or Engineering, MBA or MS desired

·         5 or more years or work experience in the medical device industry

·         Minimum of 3 years experience handling customer complaints, investigations and/or MDR, Vigilance reporting required

·         Excellent understanding of 21 CFR Part 803

·         Experience with catheter bases or cardiac assist devices is a plus

·         Ability to communicate ideas and information clearly, effectively and frequently (both oral and written)

·         Solid judgment and problem solving skills

·         Execute tasks in a timely manner without direct supervision

·         Ability to prioritize tasks

·         Strong computer and database management skills

·         Must be proficient in Microsoft Office Suite, and working knowledge of SAP desired

 

Qualified candidates send a Microsoft Word version of your resume to: mcave@mri-boston.com

 

Keywords: Regulatory, Engineer, medical device, cardiac, catheter, heart, blood, SAP, 21 CFR Part 803, Life Sciences, compliance