HCN Healthcare Recruiting

 
  Manager, Product Complaint and Field Support
 
 Responsibilities
-As the process owner for Product Complaint Handling for the Customer Solutions Group (CSG), the United States Regional unit, the manager supports the IKM, CT, MR, AX and SP Business Unit’s DCUs (Designated Complaint Handling Unit) in the processing of complaints.
-Establish clear policies and procedures for complaint handling within CSG that are compliant with current regulations.
-Ensure complaint and MDR reporting requirements are understood and met
-Support the reporting and follow-up of product recalls
-Remain current on related regulations and guidelines published by FDA and international regulatory authorities
-Research various actions taken by FDA and other regulatory bodies to gain insight into current enforcement practices and the Agency’s rationale for such actions
-Provide interpretations & direction to appropriate company personnel regarding the regulatory requirements relevant to the Product Complaint and Field Support department.
-Initiate changes to practices and procedures to ensure compliance with internal and external requirements
-Design and provide training on topics related to the compliance of the Product Complaint and Field Support department’s SOPs for all applicable employees.
-Bring regulatory compliance questions/issues to the attention of senior management
-Support development of Med QM&RA requirements, procedures, and guidance documents.
-Participate in internal compliance inspections and audits, as well as support other Med units during such inspections as requested
-Ensure timely filing of facility registrations and device listings of all designated facilities
-Support as needed the electrical certification of imported products through coordination with the internal testing laboratory, installation personnel and field certification organizations.
-Ensure timely filing of X-ray installation via form 2579 and support related field inquires as necessary.

Requirements:
- Education: Bachelors Degree or equivalent combination of education and experience.  A Bachelors Degree in engineering or other technical discipline is preferred.
- Knowledge: Must be able to acquire an understanding of the technology, products, and procedures of the supported modalities.  A thorough understanding of related U.S. Regulatory laws to ensure compliance.  Strong written and oral communication skills in order to:
- Facilitate communications with foreign counterparts
- Communicate effectively with FDA and minimize FDA inquires
- Present and dissemination training programs/information to company personnel
- Develop internal documents and procedures to increase overall efficiency and reduce error / cost.
Organizational skills to insure timely management of issues
- Experience: Minimum of 5 years experience with the management of complaints, MDR and recalls
Travel: Approximately 10 days domestic and 5 days international

Location:  PA

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