It is MEDRAD's mission to be a worldwide market leader of medical
devices and services that enable or enhance diagnostic and
therapeutic imaging procedures. MEDRAD performance is a result of
an unrelenting commitment to improving healthcare, to upholding
standards of excellence, and to responsible activities for the
benefit of our customers, shareholders, employees, and communities.
These values are expressed through our culture and philosophy, as
well as our ethical and corporate responsibility policies. MEDRAD
has over 1, 8 00 global employees, 1,200 of whom are in the
Pittsburgh area. MEDRAD's European headquarters office is located
in Maastricht, The Netherlands. Our Asian headquarters office is in
Osaka, Japan with additional international offices located in
France, Germany, Italy, China, UK, Brazil, Norway, Belgium, Sweden,
Denmark, Singapore, Egypt, Mexico, Cyprus and Australia.
The Clinical Complaint Specialist (CCS) is primarily responsible
for utilizing clinical knowledge to assist in the maintenance of
MEDRAD's Vigilance/Complaint Handling System to ensure compliance
to worldwide regulations. They will analyze information from
customer complaints and reports trends, as necessary and assist
with both internal and compliance audits and product recalls. The
CCS monitors FDA Alerts and communicates information, as necessary
and insures customer satisfaction through rapid response, trending,
and resolution of underlying issues. Challenges include maintaining
current knowledge of MEDRAD product lines and processes as well as
changing regulatory, business, and market environments. Additional
responsibilities include:
1. Based on clinical knowledge, handles customer complaints on a
Worldwide basis.
2. Assist product recall process on a global basis, in compliance
with regulatory requirements.
3. Demonstrate full competence with MEDRAD's entire product line in
terms of our product capabilities across all modalities.
4. Remain current on new products, new technologies, and trends in
the medical device industry.
5. Continually improve complaint management processes.
6. Analyze complaint trends and report, as necessary.
7. Assist in all FDA and Notified Body Audits.
8. Provide general compliance support and guidance. Alert
management and other Quality System Compliance personnel of
relevant regulatory risks and regulatory implications of various
issues.
Technical/Behavioral Requirements:
1. Associate's Degree Required, Bachelor's Degree Preferred.
2. Four (4) years experience in Cardiovascular or Interventional
Radiology and Registered Radiologic Technologist (A.R.R.T.)
required.
MR Technologist and CT Technologist experience preferred.
3. Two to three (2-3) years business Computer Skills, including
MSOffice and SAP required (Experience with Avenue desirable).
4. Two to three (2-3) years customer relations skills.
5. Strong interpersonal and communication skills required.
6. Strong competency in Customer Focus, Driving for Results,
Integrity and Trust, Ethics and Values and Compassion.
7. Proven ability to demonstrate at minimum, MEDRAD s Team
Contributor competencies: Action Oriented, Perseverance, Dealing
with Ambiguity, Learning on the fly and Problem Solving.
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