Job Responsibilities:

The Clinical Complaint Specialist will be responsible for the administration and decisions related to of all complaints and regulatory reporting decisions associated with Abiomed products.

Principle Duties and Responsibilities:

• Ensure compliance to U.S. and International medical device complaint reporting requirements
• Conduct follow-up interviews with Abiomed Field Team and/or external customers to gain clinical and technical information needed to make reporting decisions
• Provide clinical support to the engineering team, as applicable
• Participate in the SPR outreach program visiting customers
• Receive, enter and process customer complaints for all Abiomed product lines; Assess each for regulatory reporting requirements and escalate decisions if necessary
• Complete and submit MDRs and follow-up reports to FDA and International Regulatory bodies within required timeframes
• Maintain complaint and MDR file documentation in accordance with applicable global regulatory requirements
• Coordinate customer correspondence in response to complaints
• Maintain awareness and knowledge of domestic and international complaint handling and reporting regulations and changes to the regulations

• BA/BS required in Life Sciences or some medical discipline; MS or RN preferred
• 5 years experience in the medical device industry interacting with in-house medical staff and outside physicians and nurses strongly preferred
• Minimum of 2 years experience having clinical customer complaints resolution responsibility as well as investigations and/or MDR/Vigilance reporting required
• Excellent understanding of 21 CFR Part 803
• Experience with life-sustaining (FDA Class III or PMA) devices is preferred
• Excellent analytical and problem solving skills
• Ability to communicate ideas and information clearly, effectively and frequently (oral and written)
• Ability to execute tasks in a timely manner without direct supervision; able to prioritize tasks
• Must be proficient in Microsoft Office Suite; Working knowledge of SAP desired

ABIOMED is an Equal Employment Opportunity/Affirmative Action employer.  We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.