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The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of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.
Medical Device, Postmarket Surveillance, Quality/Risk Management
Our client, a growing medical device manufacturer, has engaged GForce Life Sciences to identify a Clinician / Clinical Specialist to assist in Remediation in a post market surveillance department and to assure our client’s products, processes, procedures, and systems continue to comply with regulatory requirements due to findings from an external audit performed.
Duties / Expectations of Role
Responsible for evaluating identified hazards to determine possible harms and their associated severities.
May assist in defining usage requirements and completing targeted risk benefit analysis as well as generic guidance from a clinical perspective.
Responsible for remediation of quality and adverse event complaint records involving manufactured products.
R.N. or higher accreditation with clinical experience of relevance to Class I, II & III products.
Demonstrates high quality clinical competence
Term & Start
9 months +
Unfortunately, remote work is not an option for this engagement
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.