Synthes Device Work Values

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:

A hiring company that offers alternative approaches to pay, performance bonuses, and/or equity in the firm is very attractive to you. You're generally less interested in working for an organization offering only traditional, salary-based compensation, one with limited opportunity to acquire equity in the firm, or one that does not actively promote skill development. In addition, you are more likely to choose a company that offers a variety of internal career options, with defined career paths. You view the learning of new skills and development of your expertise as key to your career advancement. These aspects of an organization may become even more important to you as you progress in your field, and are especially critical if you change career or occupation.

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

These are some of the questions we asked our climbers about their experiences with Synthes Device: