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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The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of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.
Consultant, Medical Devices, Product Surveillance/Adverse Events
This position is responsible for the investigation and resolution of product complaints of all scopes for a large division. Required to communicate in an effective manner with internal employees, the sales force, and medical professionals. Cooperates with a staff of salaried and technical employees. Must be committed to corporate goals of customer satisfaction and continuous improvement.
Duties / Expectations of Role
Authors explant examination reports and other written documentation for internal and external customers as required.
Investigates customer complaints, drives timely root cause analysis, assesses the scope of complaints, and leads HHE creation as necessary to assess patient/user risk.
Knowledge of MDRs, MDVs, and associated regulations
Experience and knowledge of the Post Market Surveillance process- complaint processing, investigation, assessment
Interfaces with Development, Manufacturing, Quality Assurance, and other functional areas to ensure thorough issue root cause, identify and formulate corrective actions, and initiate corrective action plans where applicable.
Serves as key point person for the sales force and health care professionals to verify and clarify complaint information.
Provides product and process technical training to salaried and hourly staff members.
Prepares and presents cases to the Product Safety Review Board as necessary.
Supports Product Surveillance Department in all aspects of investigations and corrective actions arising from complaints and field actions.
Serves as Core Team member for the Product Surveillance Department at various design review, testing protocol, and PRPR functions.
Serves as point person for the Audit Department or other functional areas in compliance and process audits as required.
Proficient with use of complaint and quality related IT systems and tools.
Effective experience in technical report writing skills.
Excellent oral and written skills.
Able to work independently.
Root cause analysis,
Strong understanding of risk management,
Strong time management and organizational skills.
Proven leadership, interpersonal, negotiating, and conflict resolution skills
GForce Life Sciences connects highly coveted consultants to the needs of life sciences leaders. Regulatory pressures, altering market demands and healthcare refinement are changing the landscape of the global life sciences industry. Patients, providers, payers, and regulators are seeking a higher quality of care and better therapeutic benefits, along with reduced costs and enhanced transparency.
With a 98% success rate, GForce Life Sciences has worked with some of the world’s leading pharmaceutical and medical device companies to address these challenges by providing consultants to assist our clients in delivering on the promises they have made to their clients (internal and external). GForce recognizes that there is no “one-size-fits-all” approach to achieving growth and battling industry-wide challenges, therefore we begin with your specific needs and work from there to identify the consultant or team that is the best fit.
Unlike larger, “factory firms,” our boutique approach allows us to hand-pick and closely monitor the best consultants for your company and projects. Finally, we back our services with the industry’s leading technology infrastructure, assuring agile, transparent, personalized consulting solutions and business reporting intelligence.