Senior Regulatory Affairs Specialist job – BIOTRONIK – Lake Oswego, OR

Senior Regulatory Affairs Specialist


12 reviews

Lake Oswego, OR

Full-time, Contract

Please join us as

Senior Regulatory Affairs Specialist

We’re looking for a new Regulatory Affairs Specialist to join our Regulatory and Compliance team. The right candidate will prepare 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. The team is dynamic, and Biotronik is growing – it’s a very exciting time to join the team.

Your Responsibilities

Your Profile

  • 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.
  • Lead regulatory aspects of product launches and coordinate with team members to ensure success introducing new products.
  • Provide direction, advise and mentor other regulatory specialists
  • 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.

POSITION Requirements:

  • Bachelor’s degree (or equivalent) in biomedical or electrical engineering, or related science.
  • Four to six years FDA medical device and/or combination product experience.
  • Experience authoring and preparing submissions (e.g. IDE, PMA, 510(k))
  • Cardiac Rhythm Management and/or Vascular Intervention product experience is a plus
  • 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.

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

Are you interested? Please apply online! We are looking forward to welcoming you.

US-Lake Oswego

Working hours: Full-time

Type of contract: At-Will Contract

Job ID: 10282

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.

12 reviews

Biotronik (Biotronik SE & Co. KG; Biotronik Worldwide) is a privately held multinational biomedical technology company headquartered in…

About secureteam

A Computer Programmer whose articles got mentions from the likes of The New York Times, Kissmetrics and AllTopStories. He writes articles, novels and poems; spends most of his time reading everything he could get his hands on. He is currently pursuing his Masters from The University of Illinois and holds a Bachelors in Electronics Engineering from the University of California. He is a programmer, a motivational writer and speaker.

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