Regulatory Affairs Specialist I - #20102065

BIOTRONIK


Date: Dec 8, 2021
City: Lake Oswego, OR
Contract type: Full time
BIOTRONIK

Regulatory Affairs Specialist I




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. This role is responsible for preparing pre-market submissions including 510(k), IDE, PMA and PMA Supplements / Amendments in accordance with FDA regulations and guidelines. Support activities associated with compliance to FDA regulations and policy.




Your Responsibilities


  • Coordinate, author and prepare product submissions to the FDA, including PMAs, PMA Supplements / Amendments, IDEs and 510(k)s to ensure timely approval.

  • Prepare reports required for products and devices that have been approved by investigational device exemption (IDE) and pre-market approval (PMA) process.

  • Research competitive product approval status and emerging FDA requirements and guidance to support timely approval of submissions and department objectives.

  • Work with other BIOTRONIK departments to facilitate, communicate and implement regulatory submission strategies.

  • Determine design validation and qualifications test requirements for FDA submissions of new products or product changes and provide guidance on these matters to design engineering and validation personnel.

  • Review design validation and qualification test results and prepares clear and concise summaries for submission to FDA.

  • Review product marketing and promotional materials to ensure compliance with FDA requirements

  • Review and prepare software development, verification, and validation documentation and reports for FDA submissions. Utilize knowledge of FDA software policies and guidance to assist BIOTRONIK in developing strategies for future submissions.

  • Assist with preparation and update of technical manuals and other product labeling as necessary to comply with FDA requirements; review labeling generated for compliance with FDA and BIOTRONIK requirements.

  • Interface with Regulatory Affairs counterparts and research & development personnel at BIOTRONIK in Germany and Switzerland.

  • Gain knowledge of BIOTRONIK (Germany and Switzerland) standard operating procedures as they apply to BIOTRONIK, Inc. processes and FDA requirements.

  • Other duties as assigned.



Your Profile


  • Bachelor’s degree (or equivalent) in biomedical or electrical engineering, or related science.

  • Minimum 0-2 years of experience working in a regulated industry (medical device and/or pharmaceuticals).

  • Positive attitude and willingness to work on a team.

  • Ability to work independently and as a team leader.

  • Ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.

  • Technical writing experience required.

  • Excellent computer skills, 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.



Travel:


  • Limited travel is required, usually less than 10% a year.



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




Job ID: 48422 | 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.

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