As a regulatory professional, confidence comes from having the answers you need. But what do you do when the answers just aren't there? 2014 RAPS will give you the know-how to tackle your toughest issues.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Abbott Molecular's mission is to advance molecular testing solutions that guide life's most profound decisions. The Des Plaines, IL location has a new opening for Complaints Manager. This leader will partner with internal stakeholders and customers to drive improvements throughout the complaint handling process.
Incumbent is responsible for implementing and progressively improving the customer complaint management process within the Quality Management System at Abbott Molecular.
Incumbent directly manages five (5) exempt level employees. Responsible for goal setting, development planning, succession planning, and performance management.
Incumbent is responsible for the design, performance, and governance of the Complaint Management program within Abbott Molecular, which includes:
- Quality System Procedures/Forms
- IT Solution (Current: SmartSolve Pilgrim ; Future: 123 Compliance)
- Training Curriculum
- User Awareness and Competency
- Key Performance Indicators (KPIs)
4-year degree in a clinical, scientific, or technical discipline from an accredited university
Minimum 5 years of customer complaints management experience in the medical device industry
Minimum 5 years of people/talent management experience
Minimum of 5 years of FDA experience, including participation in device inspections
RAPS certification preferred
United States > Des Plaines : DP01 Floor-3
Yes, 5 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
At Abbott, we are enthusiastic, energetic and committed to doing great work every day. Our employees are passionate about helping to translate science into lasting contributions to health care and the health of people worldwide. At the heart of our organization is our "Promise for Life"—a statement that embodies our company's commitment to employees, shareholders, local communities and the people ...who depend on our company and products to live healthier lives.Vital to our promise is the speed in which we act, respond and deliver. As Abbott employees, we are ready to meet change and challenges head-on. As a result, we are a company that adapts quickly, and through our passion for innovation we are able to continually create a pipeline of products that help improve the length and quality of life around the world.We are proud of our rich, more than 120-year history. We continue to be driven to advance leading-edge science and technologies, support diversity, focus on exceptional performance and earn the trust of those we serve.