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Sr. Regulatory Affairs Specialist at Heraeus Medical Components LLC

Posted in Engineering 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: St. Paul, Minnesota





Job Description:






Sr. Regulatory Affairs Specialist

Location St. Paul – Minnesota

Permanent  

Full Time

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of nearly 15,000 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.




Roles and Responsibilities


  • Provide regulatory affairs support for component, contract and finish device manufacturing

  • Develop and execute on Regulatory Affairs Plans to support product realization activities

  • Supervise complaint handling process and other post market surveillance activities relate to finished devices

  • Support global sites in maintaining ISO certifications and track correspondence from Notified Bodies

  • Submit request for Certificates from the FDA for International Regulatory Compliance and Export Requirements

Qualifications


  • 3-5 years in a medical device regulatory affairs or quality department and undergraduate science, engineering or technical writing degree

  • 0-3 years in a regulatory affairs role with US FDA and EU responsibility

  • Experience with cardiovascular and/or neurology medical devices preferred

  • US FDA Regulatory Affairs  and US FDA Medical Device Listing and Establishment Registrations experience

  • Post Market Surveillance Reporting

  • Technical File and Design Examination EC Certificates

  • Understanding of International Regulatory Affairs requirements



If you want to do more than make a living, at Heraeus you can make a difference. We can provide you with the opportunity - and Open Space - where your ideas and career can grow and advance. We offer attractive compensation, top-notch benefits, and an ideal environment that supports your professional development. You can find more information at www.heraeus.com/careersusa.

Keywords: Regulatory Affairs