Job Description:

Administrative Assistant - Regulatory Affairs & Quality

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

BIOTRONIK is looking to add a Regulatory Affairs Specialist I to our Regulatory Affairs Team.  The Administrative Assistant - Regulatory Affairs & Quality will be responsible for administrative activities associated with medical device regulations and the quality management system. This individual will support the VP, Regulatory and New Product Development and the associated department for all administrative tasks including compiling and organizing materials for FDA submissions and compliance activities. Additionally, they will ensure tasks are handled in accordance with BIOTRONIK quality system requirements and company policies. 

Currently this is a remote position that, once our campus reopens, will ultimately be hybrid, located in our Lake Oswego, OR office.  This is a full-time position, with limited flexibility of working hours..  

Your Responsibilities

• Coordinates with and assists cross-functional team members in the management of documents including reports, labeling and technical manuals and change management process. 


• Formats, publishes, builds e-copies and archives information for FDA submissions and quality system records


• Maintains FDA device listing and UDI process. 


• Ensures information and correspondence are properly archived 


• Contributes to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of documentation


• Tracks statuses of projects and documents and reports to internal stakeholders


• Trains personnel on internal procedures and systems


• Maintains complete, accurate and current files of FDA submissions and controlled documents


• Prepares and revises technical manuals, box labels and other documents as necessary. 


• Assists in obtaining and maintaining translation documentation files. 


• Coordinates offsite document storage


• Coordinates with Quality Systems to ensure systems are maintained in accordance with FDA regulations


• Prepares and organizes expense reports for department management.


• Other duties as assigned

Your Profile

• Ability to work on several projects concurrently, prioritizing work in consultation with manager


• High school diploma (or equivalent) required, College Degree (Associates or Bachelors), preferred


• At least three years related experience in office setting


• Experience working in the medical device industry, preferred


• Quality or Regulatory systems experience, preferred


• Experience with project management software, preferred


• Excellent organizational skills and attention to detail


• Superior proficiency with Office Suite including Microsoft Word and Excel


• Proficiency with Adobe Acrobat


• Ability to work with employees at all levels in the organization


• Demonstrated ethical behavior, including maintaining confidentiality of proprietary information


• Accountable for own behavior and actions


• Ability to clearly convey or exchange information with stakeholders within the organization.


• Self-motivated

Travel:

• Occasional domestic travel may be required to attend professional development events. 

Work Enviornment:

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, headsets, phones, photocopiers, filing cabinets and fax machines.

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Lake Oswego, OR | Working hours: Full-time  | Type of contract: Undefined 

Apply now under: www.biotronik.com/careers

Job ID: 49782  | Contact: Amanda Willott  

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

 

Apply Now