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Senior Regulatory Affairs Specialist

Date: Jul 14, 2021

Location: St. Paul – Minnesota, US, 55127

Company: Heraeus

[title]
Senior 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 around 14,800 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.

 
 

 

 Your Role 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
  • Create and defend regulatory submissions and approvals (CE mark technical documentation, US FDA filings, other country registrations)
  • Responsible for leading one colleague, who will be supporting you on your activities

 

What is required for this role:

  • Undergraduate degree science, engineering or technical writing with 3-5 years in a medical device regulatory affairs or quality department0-3 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
  • EU Medical Device Regulation experience preferred. Understanding of International Regulatory Affairs requirements
  • Post Market Surveillance Reporting
  • Leadership skills

 


Nearest Major Market: Minneapolis