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 June 30th, 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 Affairs Manager located in beautiful Pacific NW near Portland, OR. (Relocation help will be provided).
The successful candidate will prepare pre-market submissions including 510(k), IDE, PMA and PMA Supplements in accordance with FDA regulations and guidelines. You will support activities associated with compliance to FDA regulations and policy including quality system requirements and other associated legal and ethical concerns. You will plan, develop and write Standard Operating Procedures (SOP) to support our compliance program, interact with various personnel to implement the SOPs, 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 also perform periodic internal audits of all activities that are affected by FDA regulations or other requirements (i.e., Code of Ethics). You will review and monitor the ongoing status of our procedures for labeling products for US distribution, participate in FDA facility inspections at BIOTRONIK, Inc. You will work with management to develop strategies for addressing compliance requirements for clinical studies and regulatory submissions, assist with personnel training regarding compliance activities including new employee compliance orientation, prepare clear and concise product descriptions for submission to FDA including principles of operation, safety warnings, and precautions, oversee, monitor and provide training of personnel in compliance to Health Insurance Portability and Accountability Act of 1996 (HIPAA) and participate in our Corrective and Preventative Action (CAPA) system. You will also research competitive product approval status and emerging FDA requirements to support timely approval of submissions and department objectives, determine design validation and qualifications test requirements for new product FDA submissions and provide guidance on these matters to design engineering and validation personnel and review and prepare software development, verification, and validation documentation and reports for new product FDA submissions.
The position requires Bachelor's degree in biomedical or electrical engineering, or related science and three years medical device and/or FDA experience. Ability to work independently and as a team leader, excellent communication skills and the ability to work with all levels of the Company is required. Strong organizational skills and attention to detail, excellent computer skills, and knowledge of Microsoft Office package, Windows and e-mail systems is necessary. Technical writing experience is desirable.
Please send your resume to careers@biotronik.com for consideration.