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Synthes Device Work Values
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Daily Duties at Synthes Device:
As a Regulatory Affairs Specialist, I provided regulatory, auditing, legal, and medical writing support to Synthes internal regulatory and legal team members by writing a Corporate Integrity Agreement along with another consultant. This CIA was required by the OIG in response to six patient deaths related to a Norian surgical bone cement clinical trial that was not reported to the FDA. My duties included auditing (comparison of existing QC/QA/Regulatory SOPs with those required by the FDA under 510k and PMA guidelines). The purpose of the CIA was to enforce reporting of adverse events or violations of criminal/civil/administrative and to provide detailed requirements of clinical, legal, regulatory, sales, marketing and engineering departments regarding Compliance Reporting. The production of this CIA -2- was also an opportunity to create a REMS program (Risk Evaluation and Mitigation Strategy). The CIA also required rewriting of corporate policies, procedures, training manuals and QSM documents. Also the CIA was created to support the corect filing of 510(k)s, Premarket Notifications, Investigational Device Exemption applications, and Technical Files as well as support for developing clinical strategies, IDE protocols, CRFs, and informed consents for various medical device clinical trials. Consultancy ended in August of 2010
What they like about Synthes Device:
You give high priority to hiring firms with prestige. Market reputation and prestige of a firm may be determined through on-line research, and conversations with individuals working in your target industry. Note that firms "in the public eye" receive a great deal more critical publicity and attention than those operating with more anonymity. So as you assess your employment opportunities, be sure to seek out the positive aspects of the firm's reputation in addition to noting negative publicity the company may have received.
Tags
intellectual property, biotech, device, regulatory affairs, corporate integrity agreements, pharmaceutical, litigation, mediation, negotiations, contracts, partnerships, licensing agreements, alliances, FDA, compliance, data discovery, electronic data collection, data analysis
Skills
Presentation, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Leadership , Patent Searches, IP Negotiations and Litigation, Biosimilar 505(b)(2) and Generic IP Analysis, In-Licensing and Out-Licensing Deal Making
Information about Synthes Device
Company Rank: Not Available
Average length of employment : 0 years
Average salary of employees: $90,000
These are some of the questions we asked our climbers about their experiences with Synthes Device:
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