Compliance Specialist

BIOTRONIK, Inc.

Location: Lake Oswego, Oregon-Portland 97035
Posted on: 7/25/2008 2:16:16 PM
Postion type: Full time
Job Code: 1267
Required Education: Bachelor's Degree
Salary:

DESCRIPTION
Founded in 1963, BIOTRONIK, Inc. is a pioneer in developing innovative technologies and medical devices that save and enhance the quality of life for millions of individuals living with cardiovascular conditions. With a growing base of over 3,600 employees worldwide, we're continually looking for talented professionals with the passion and drive for excellence to join our mission.

BIOTRONIK, Inc. now has an exciting opportunity available for a Compliance Specialist
in beautiful Portland Oregon. Relocation assistance will be provided.

POSITION SUMMARY:

The Complaince Specialist supports activities associated with FDA regulation and policy compliance including quality system requirements and other associated legal and ethical concerns.

RESPONSIBILITIES:

•Draft, prepare and update compliance policies and procedures upon direction from Compliance Management.
•Coordinate day-to-day compliance activities including but not limited to directing and answering compliance questions based on current policies and procedures.
•In cooperation with the other departments; plan, develop and write Standard Operating Procedures (SOP) to support the BIOTRONIK, Inc. compliance program.
•Interact with BIOTRONIK personnel to implement the SOPs.
•Assist Compliance Management with training, education and communication campaigns designed to support BIOTRONIK’s culture of compliance.
•Perform Sales Training and New Hire Orientation training.
•Oversee, monitor and provide training of personnel in BIOTRONIK, Inc.’s compliance to Health Insurance Portability and Accountability Act of 1996 (HIPAA).
•Perform periodic internal audits of all activities at BIOTRONIK, Inc. that are affected by FDA regulations or other requirements (i.e., Code of Ethics).
•Prepares for and participates in audits, both internal and third party, and drives any corrective actions resulting from these audits.
•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.
•Participate in FDA facility inspections at BIOTRONIK, Inc. and support BIOTRONIK, GmbH & Co. during FDA foreign inspections, as required.
•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 BIOTRONIK’s products. This monitoring may be realized by a role in the Complaint Review Committee (CRC) and review of complaint files.
•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.
•Review and monitor the ongoing status of BIOTRONIK’s procedures for labeling products for US distribution. This includes both market released and investigational devices.
•Participate in BIOTRONIK, Inc.’s Corrective and Preventative Action (CAPA) system.
•Provide guidance and support to CAPA users regarding the CAPA process, CAPA training and CAPA documentation.
•Gain knowledge of BIOTRONIK (Germany and Switzerland) standard operating procedures as they apply to BIOTRONIK, Inc. processes and FDA requirements.
•Other duties as assigned.

TRAVEL:

•Limited travel is required, usually less than ten percent a year.

REQUIREMENTS:

•Bachelor’s Degree in Biosciences or Healthcare related field.
•Three years medical device and/or pharmaceuticals experience.
•Working knowledge of Medical Device and/or Pharmaceutical Regulations.
•Strong analytical skills. Reliable and timely decision maker (decisions based on relevant information, alternatives, risk).
•Ability to apply project management, and change management techniques to internal projects.
•Positive attitude and willingness to work on a team.
•Ability to work independently and as a team leader.
•Technical writing experience desirable.
•Proficient PC application skills, including knowledge of Microsoft Office package, Windows and e-mail systems.
•Excellent communication skills and the ability to work with all levels of the Company.
•Strong organizational skills and attention to detail.

For consideration, please send your resume to:
careers@biotronik.com
Please include in the subject line "Compliance Specialist BioSpace1267"

For more information on Biotronik, Inc. please visit our website at:
www.biotronik.com Label