| RegulatoryCareers.com | |||
| Jobs Index - Index of recent job listings. | |||
| Resumes Index - Index of recently posted resumes. | |||
| RegulatoryCareers.com - Register here for more Regulatory Affairs Services Jobs | |||
| |||
| Clinical Specialist PA Open (J#30074) Siemens is one of the worlds largest suppliers to the healthcare industry. The company brings trendsetting innovation in imaging and lab diagnostics, therapy, healthcare information technology solutions, consulting and support services to healthcare providers worldwide. Bring us your talent and well bring you the resources and tools to succeed. Welcome to our world of opportunities. Welcome to Siemens Medical Solutions. Senior Regulatory/Clinical Specialist Malvern, PA Reports to Director of Regulatory and Clinical Affairs and is responsible for regulatory submissions to FDA for medical device clearance and approval as well as for clinical studies. Will prepare submissions for new and changed products as required to ensure timely approval for market release and will interface with multiple functional areas, geographies and divisions across various modalities within Siemens Healthcare. Other responsibilities include: Coordinates with the Director of Regulatory and Clinical Affairs in the preparation, review and submission of IDE applications for clinical studies, as well as other clinical studies Reviews all submissions to FDA for completeness, truthfulness and compliance with regulations as well as the advertising and promotional material and device labeling for regulatory compliance Controls the introduction of product through the United States market through management of the production introduction process Initiates changes to practices and procedures to support compliance requirements Provides interpretations and direction to applicable company personnel regarding the regulatory aspects associated with relevant functions and provides general guidance or training support of professional staff A BS/BA in scientific or engineering discipline or equivalent combination of education and experience and 10-15 years of successful experience in related field. Experience in the medical device industry preferred, but relevant experience in the pharmaceutical industry will be considered. Candidates must have excellent writing skills in the preparation of technical documents based on technical reports prepared by other technical functions. A thorough understanding of US FDA regulatory laws and requirements to ensure compliance to regulations without hindering business and growth is needed. This position may require domestic travel several days per month and international travel several times per year. To apply, please visit our career website and enter requisition # 74048 at the job search page. Siemens Medical Solutions is one of the world's largest suppliers to the healthcare industry and an Equal Opportunity Employer. www.usa.siemens.com/careers | |||
| RegulatoryCareers.com - Register here for more Regulatory Affairs Services Jobs | |||
| RegulatoryCareers.com is the premier job search website focused specifically on the employment needs of Regulatory Affairs Companies and Professionals. Use this as an exclusive resource to find your next job or employee. We guarantee that you will be pleased with the special focus of this web site. | |||