This is the official site of the Oregon Bioscience Association (OBA).
Our mission is to promote the growth and quality of the bioscience industry in Oregon. We continually seek ways to support our membership community in achieving their full scientific, economic and social potential.
OBA is a non-profit association with membership open to any company, organization or individual with an interest in biotechnology, medical devices, or the life sciences.
Posted May 29th, 2008
BIOTRONIK is one of the world's leading manufacturers of products and services for cardiac rhythm management and vascular intervention and is represented in over 100 countries worldwide. We now have an opening for a Regulatory and Compliance Specialist located in beautiful Pacific NW near Portland, OR. (Relocation help will be provided).
The successful candidate will support activities associated with compliance to FDA regulations and policy including quality system requirements and other associated legal and ethical concerns. You will draft, prepare and update compliance policies and procedures upon direction from Compliance Management. You will coordinate day-to-day compliance activities including but not limited to directing and answering compliance questions based on current policies and procedures; plan, develop and write Standard Operating Procedures (SOP) to support our compliance program, and interact with BIOTRONIK personnel to implement the SOPs. You will also assist Compliance Management with training, education and communication campaigns designed to support BIOTRONIK?s culture of compliance. You will perform Sales Training and New Hire training; oversee, monitor and provide training of personnel in compliance to Health Insurance Portability and Accountability Act of 1996 (HIPAA). You will perform periodic internal audits of all activities at BIOTRONIK, Inc. that are affected by FDA regulations or other requirements (i.e., Code of Ethics), prepare for and participate in audits, both internal and third party, and drive any corrective actions resulting from these audits. You will update quality system documentation such as forms, work instructions, and procedures in support of continuous improvement activities, perform quality system and process audits as per the established schedules. You will also participate in FDA facility inspections at BIOTRONIK, Inc. and support BIOTRONIK, GmbH & Co. during FDA foreign inspections, as required. You will monitor and maintain effective policies and procedures to assure compliance with FDA?s tracking, complaint handling and Medical Device Reporting (MDR) regulations as they apply to our products. You will assist in preparation of annual reports required for products and devices that have been approved by pre-market approval (PMA) process, interface with compliance counterparts and quality assurance personnel at BIOTRONIK in Germany and Switzerland to respond to FDA queries relating to MDRs. You will also review and monitor the ongoing status of our procedures for labeling products for US distribution, participate in our Corrective and Preventative Action (CAPA) system, provide guidance and support to CAPA users regarding the CAPA process, CAPA training and CAPA documentation.
The position requires Bachelor?s Degree in Biosciences or Healthcare related field and three years medical device and/or pharmaceuticals experience. Strong analytical skills, prudent decision-making skills and ability to apply project management, and change management techniques to internal projects are necessary. Excellent communication skills and the ability to work with all levels of the Company, strong organizational skills and attention to detail are also required. Proficient PC application skills, including knowledge of Microsoft Office package, Windows and e-mail systems and ability to work independently and as a team leader. Technical writing experience is desirable.
For consideration please send your resume to: careers@biotronik.com