Regulatory Affairs Specialist

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Date: May 26, 2023

Location: St. Paul – Minnesota, US, 55127

Company: Heraeus

Regulatory Affairs Specialist

Location White Bear Lake

Permanent

Full Time

About Heraeus

Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a broadly diversified and globally leading family-owned technology company, we combine materials expertise and cutting-edge technologies to create products used all over the world with one thing in common: World-class quality.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, a FORTUNE Global 500 listed company, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

The Following Challenges Await You:

Initiate global regulatory strategies for new products and post-market changes.
Review post-market changes for devices currently marketed to determine regulatory impact.
Prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance.
Prepare and/or review technical documentation for Health Canada and submit regulatory recertifications and change notifications as appropriate.
Prepare and/or review appropriate documentation for initial submissions, change notifications, or renewals for EU MDR CE marked devices.
Keep up to date with changing regulations and educate cross functional peers on new medical device regulations, such as EU MDR or relevant guidance published by the FDA, etc.
Review international submissions to be submitted by our medical device company customers/partners.
Review and approve changes to currently marketed devices to determine impact to regulatory clearances / approvals.
Answer customer questions and provide letters/other documentation as is appropriate.
Support Notified Body and other regulatory agency audits.
Review and approve the rationale for reporting complaints to regulatory agencies and/or customers.
Ensure understanding of all quality policy/system items that are applicable.
Review and/or approve customer agreements for regulatory language that is relevant to the services provided.
Ensure that the information provided through the FURLS registration system with the FDA and the MDALL database in Health Canada is up-to-date and accurate regarding establishments licensing, owner/operator and medical device listings.
Update GUDID and/or EUDAMED database as needed for new and existing products.

Your Profile:

Strong written and verbal communication skills
Problem solving and/or troubleshooting experience
Computer and data entry skills
Strong understanding of the administrative aspects of document management
Team oriented and able to effectively manage and prioritize multiple projects
General knowledge of medical terminology
Excellent organizational and computer skills (Electronic Quality Management Systems (eQMS), Enterprise Software (ERP), word processing, spreadsheets, databases)
Minimum Requirements:
Undergraduate degree with a minimum 3 years of regulatory affairs, engineering, or quality medical device experience, or relevant Regulatory Affairs Certifications with lesser experience, or advanced degree with 2 years of medical device regulatory experience
Preferred Requirements:
US and International medical device regulatory submission experience
Experience with working with PMA or 510(k) devices
Knowledge of FDA, EU MDR, Health Canada, MHRA, MHLW, ANVISA and TGA requirements
Previous regulatory body/agency interactions
Vigilance/Adverse Event Medical Device Reporting experience

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Nearest Major Market: Minneapolis